Download PDF

Clinical Trial Results:
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

Summary
EudraCT number	2014-001477-13
Trial protocol	DE
Global end of trial date	03 Mar 2017

Results information
Results version number	v1(current)
This version publication date	25 Jun 2017
First version publication date	25 Jun 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

M14-227

ISRCTN number

US NCT number

NCT02219477

WHO universal trial number (UTN)

Sponsor organisation name

Abbvie Deutschland GmbH & Co.KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB

Public contact

Krystal Gibbons, BS, AbbVie, krystal.gibbons@abbvie.com

Scientific contact

Eric Cohen, MD, AbbVie, eric.cohen@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Mar 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Mar 2017

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study were to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected subjects with decompensated cirrhosis.

Protection of trial subjects

Participant and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Nov 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 9

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

United States: 22

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

Eligible subjects had up to 42 days following the Screening Visit to enroll into the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Group 1: GT1B

Arm description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants

Arm type

Experimental

Investigational medicinal product name

ombitsavir/ritonavir/paritaprevir

Investigational medicinal product code

ABT-450/r/ABT-267

Other name

ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as norvir

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Paritaprevir co-formulated with ritonavir and ombitasvir. Ombitasvir/paritaprevir/ritonavir was taken orally as 2 tablets QD which corresponds to a 25 mg ombitasvir/150 mg paritaprevir/100 mg ritonavir dose QD.

Investigational medicinal product name

dasabuvir

Investigational medicinal product code

ABT-333

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Dasabuvir was provided by AbbVie as 250 mg tablets. For GT1-infected subjects, dasabuvir was also taken orally as 1 tablet BID, which corresponds to a 250 mg dose BID.

Investigational medicinal product name

ribavirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

RBV was provided as 200 mg tablets and was taken orally. It is understood that RBV typically has weight-based dosing for subjects, 1000 to 1200 mg divided twice daily, per local label.

Group 2: GT1 non-B

Arm description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

Arm type

Experimental

Investigational medicinal product name

ombitsavir/ritonavir/paritaprevir

Investigational medicinal product code

ABT-450/r/ABT-267

Other name

ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as norvir

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

dasabuvir

Investigational medicinal product code

ABT-333

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Dasabuvir was provided by AbbVie as 250 mg tablets. For GT1-infected subjects, dasabuvir was also taken orally as 1 tablet BID, which corresponds to a 250 mg dose BID.

Investigational medicinal product name

ribavirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

RBV was provided as 200 mg tablets and was taken orally. It is understood that RBV typically has weight-based dosing for subjects, 1000 to 1200 mg divided twice daily, per local label.

Group 3: GT4

Arm description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Arm type

Experimental

Investigational medicinal product name

ombitsavir/ritonavir/paritaprevir

Investigational medicinal product code

ABT-450/r/ABT-267

Other name

ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as norvir

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

ribavirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

RBV was provided as 200 mg tablets and was taken orally. It is understood that RBV typically has weight-based dosing for subjects, 1000 to 1200 mg divided twice daily, per local label.

Number of subjects in period 1	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Started	9	24	3
Completed	9	22	2
Not completed	0	2	1
Consent withdrawn by subject	-	1	-
Adverse event	-	1	1

Baseline characteristics

Top of page

Reporting group title

Group 1: GT1B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants

Reporting group title

Group 2: GT1 non-B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

Reporting group title

Group 3: GT4

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Reporting group values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4	Total
Number of subjects	9	24	3	36
Age categorical
Units: Subjects
< 65 years	7	20	2	29
>= 65 years	2	4	1	7
Gender categorical
Units: Subjects
Female	2	7	1	10
Male	7	17	2	26

End points

Top of page

Reporting group title

Group 1: GT1B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants

Reporting group title

Group 2: GT1 non-B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

Reporting group title

Group 3: GT4

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Primary: Percentages of Subjects with Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2

Top of page

End point title

Percentages of Subjects with Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 ^[1] ^[2]

End point description

SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, subjects with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.

End point type

Primary

End point timeframe

12 weeks after the last actual dose of study drug

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The primary endpoint was analyzed in Groups 1 and 2 only, per protocol.

End point values	Group 1: GT1B	Group 2: GT1 non-B
Number of subjects analysed	9 ^[3]	24 ^[4]
Units: percentage of subjects
number (confidence interval 95%)	100 (70.1 to 100)	95.8 (79.8 to 99.3)

Notes
[3] - ITT population: subjects who received ≥1 dose of study drug; subjects missing data = non-responders.
[4] - ITT population: subjects who received ≥1 dose of study drug; subjects missing data = non-responders.

No statistical analyses for this end point

Secondary: Percentage of Subjects With SVR12 in Group 3

Top of page

End point title

Percentage of Subjects With SVR12 in Group 3 ^[5]

End point description

SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, subjects with missing data were counted as failures.

End point type

Secondary

End point timeframe

12 weeks after the last actual dose of study drug

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This secondary endpoint was analyzed in Group 3 only, per protocol.

End point values	Group 3: GT4
Number of subjects analysed	3 ^[6]
Units: percentage of subjects
number (not applicable)	66.7

Notes
[6] - ITT population: subjects who received ≥1 dose of study drug; subjects missing data = non-responders.

No statistical analyses for this end point

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

Top of page

End point title

Percentage of Subjects With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

End point description

On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. +/-99999=not applicable; 95% confidence interval was not calculated for Group 3.

End point type

Secondary

End point timeframe

Up to 24 weeks during treatment

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	9 ^[7]	24 ^[8]	3 ^[9]
Units: percentage of subjects
number (confidence interval 95%)	0 (0 to 29.9)	0 (0 to 13.8)	0 (-99999 to 99999)

Notes
[7] - Intent-to-treat population: subjects who received ≥1 dose of study drug.
[8] - Intent-to-treat population: subjects who received ≥1 dose of study drug.
[9] - Intent-to-treat population: subjects who received ≥1 dose of study drug.

No statistical analyses for this end point

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing Relapse˅12

Top of page

End point title

Percentage of Subjects With SVR12 Non-Response Due to Experiencing Relapse˅12

End point description

Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a subject with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for subjects assigned to 12 weeks of treatment or ≥ 154 days for subjects assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method. +/-99999=not applicable; 95% confidence interval was not calculated for Group 3.

End point type

Secondary

End point timeframe

Up to 12 weeks after the last actual dose of study drug

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	7 ^[10]	19 ^[11]	2 ^[12]
Units: percentage of subjects
number (confidence interval 95%)	0 (0 to 35.4)	0 (0 to 16.8)	0 (-99999 to 99999)

Notes
[10] - Intent-to-treat population: subjects who received ≥1 dose of study drug and who had an assessment.
[11] - Intent-to-treat population: subjects who received ≥1 dose of study drug and who had an assessment.
[12] - Intent-to-treat population: subjects who received ≥1 dose of study drug and who had an assessment.

No statistical analyses for this end point

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

Top of page

End point title

Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

End point description

Improvement was defined as: • increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin • decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin • decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein • increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count • decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio. 99999=not applicable, since number of subjects=0.

End point type

Secondary

End point timeframe

Up to post-treatment Week 12

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	9 ^[13]	22 ^[14]	2 ^[15]
Units: percentage of subjects
number (not applicable)
Albumin; n=9, 22, 2	77.8	77.3	50
Bilirubin; n=9, 22, 2	66.7	72.7	100
Alpha-fetoprotein; n=9, 0, 0	33.3	99999	99999
Platelet count; n=9, 21, 2	22.2	14.3	0
International normalized ratio; n=9, 21, 2	0	0	0

Notes
[13] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[14] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[15] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.

No statistical analyses for this end point

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

Top of page

End point title

Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

End point description

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline (BL) to post-treatment (PT) Week 12 (WK12).

End point type

Secondary

End point timeframe

Up to post-treatment Week 12

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	9 ^[16]	22 ^[17]	2 ^[18]
Units: percentage of subjects
number (not applicable)	0	9.1	50

Notes
[16] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[17] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[18] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.

No statistical analyses for this end point

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Child-Pugh Score

Top of page

End point title

Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Child-Pugh Score

End point description

The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.

End point type

Secondary

End point timeframe

Up to post-treatment Week 12

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	9 ^[19]	22 ^[20]	2 ^[21]
Units: percentage of subjects
number (not applicable)	66.7	54.5	50

Notes
[19] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[20] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[21] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.

No statistical analyses for this end point

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score

Top of page

End point title

Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score

End point description

MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.

End point type

Secondary

End point timeframe

Up to post-treatment Week 12

End point values	Group 1: GT1B	Group 2: GT1 non-B	Group 3: GT4
Number of subjects analysed	8 ^[22]	21 ^[23]	2 ^[24]
Units: percentage of subjects
number (not applicable)	87.5	61.9	100

Notes
[22] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[23] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.
[24] - ITT population: subjects who received ≥1 dose of study drug and who had assessments at BL & PT WK12.

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.

Adverse event reporting additional description

A protocol-related event is defined as any event with onset or worsening reported by a subject from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the subject.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Group 1: GT1B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants

Reporting group title

Group 2: GT1 Non-B

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

Reporting group title

Group 3: GT4

Reporting group description

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Serious adverse events	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 9 (11.11%)	10 / 24 (41.67%)	1 / 3 (33.33%)
number of deaths (all causes)	0	1	1
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
POST PROCEDURAL COMPLICATION
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HEPATIC ENCEPHALOPATHY
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PANCYTOPENIA
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
GENERAL PHYSICAL HEALTH DETERIORATION
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ASCITES
subjects affected / exposed	1 / 9 (11.11%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HAEMATEMESIS
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HAEMATOCHEZIA
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
OESOPHAGEAL VARICES HAEMORRHAGE
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
VOMITING
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
HEPATIC FAILURE
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
HYPERBILIRUBINAEMIA
subjects affected / exposed	1 / 9 (11.11%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	1 / 1	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
ANXIETY
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
RENAL FAILURE
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
PERITONITIS BACTERIAL
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ELECTROLYTE IMBALANCE
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HYPONATRAEMIA
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Group 1: GT1B	Group 2: GT1 Non-B	Group 3: GT4
Total subjects affected by non serious adverse events
subjects affected / exposed	8 / 9 (88.89%)	24 / 24 (100.00%)	3 / 3 (100.00%)
Vascular disorders
HYPERTENSION
subjects affected / exposed	1 / 9 (11.11%)	0 / 24 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0
HYPOTENSION
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	3	0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 9 (0.00%)	4 / 24 (16.67%)	1 / 3 (33.33%)
occurrences all number	0	4	1
CHILLS
subjects affected / exposed	1 / 9 (11.11%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	2	0
FATIGUE
subjects affected / exposed	3 / 9 (33.33%)	11 / 24 (45.83%)	2 / 3 (66.67%)
occurrences all number	3	11	3
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 9 (0.00%)	6 / 24 (25.00%)	1 / 3 (33.33%)
occurrences all number	0	6	2
PYREXIA
subjects affected / exposed	1 / 9 (11.11%)	3 / 24 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	4	0
Reproductive system and breast disorders
BREAST PAIN
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
EJACULATION FAILURE
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	2
ERECTILE DYSFUNCTION
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
Respiratory, thoracic and mediastinal disorders
COUGH
subjects affected / exposed	3 / 9 (33.33%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences all number	3	1	0
DYSPNOEA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences all number	0	2	1
PRODUCTIVE COUGH
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
Psychiatric disorders
ANXIETY
subjects affected / exposed	1 / 9 (11.11%)	1 / 24 (4.17%)	0 / 3 (0.00%)
occurrences all number	1	1	0
DEPRESSED MOOD
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences all number	0	1	1
INSOMNIA
subjects affected / exposed	0 / 9 (0.00%)	6 / 24 (25.00%)	2 / 3 (66.67%)
occurrences all number	0	6	3
IRRITABILITY
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
MOOD SWINGS
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	3
PANIC ATTACK
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	2 / 3 (66.67%)
occurrences all number	0	0	2
Investigations
BLOOD CREATININE INCREASED
subjects affected / exposed	1 / 9 (11.11%)	0 / 24 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0
CREATININE RENAL CLEARANCE DECREASED
subjects affected / exposed	1 / 9 (11.11%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	4	0
HAEMOGLOBIN DECREASED
subjects affected / exposed	1 / 9 (11.11%)	3 / 24 (12.50%)	1 / 3 (33.33%)
occurrences all number	1	4	1
WEIGHT INCREASED
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
Injury, poisoning and procedural complications
CONTUSION
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	3	0
FALL
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	3	0
Cardiac disorders
TACHYCARDIA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
Nervous system disorders
DIZZINESS
subjects affected / exposed	1 / 9 (11.11%)	7 / 24 (29.17%)	2 / 3 (66.67%)
occurrences all number	1	10	2
HEADACHE
subjects affected / exposed	1 / 9 (11.11%)	5 / 24 (20.83%)	0 / 3 (0.00%)
occurrences all number	1	5	0
HEPATIC ENCEPHALOPATHY
subjects affected / exposed	1 / 9 (11.11%)	4 / 24 (16.67%)	1 / 3 (33.33%)
occurrences all number	1	5	1
HYPERAESTHESIA
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
HYPOTONIA
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	2
PARAESTHESIA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	3	0
RADIAL NERVE PALSY
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
SYNCOPE
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences all number	0	1	1
TREMOR
subjects affected / exposed	1 / 9 (11.11%)	3 / 24 (12.50%)	0 / 3 (0.00%)
occurrences all number	1	3	0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	2 / 9 (22.22%)	6 / 24 (25.00%)	0 / 3 (0.00%)
occurrences all number	4	6	0
LEUKOCYTOSIS
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
PANCYTOPENIA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
Gastrointestinal disorders
ABDOMINAL PAIN
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	3 / 3 (100.00%)
occurrences all number	0	3	4
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	1 / 3 (33.33%)
occurrences all number	0	4	1
ASCITES
subjects affected / exposed	0 / 9 (0.00%)	8 / 24 (33.33%)	1 / 3 (33.33%)
occurrences all number	0	8	1
CONSTIPATION
subjects affected / exposed	0 / 9 (0.00%)	5 / 24 (20.83%)	0 / 3 (0.00%)
occurrences all number	0	6	0
DIARRHOEA
subjects affected / exposed	3 / 9 (33.33%)	10 / 24 (41.67%)	1 / 3 (33.33%)
occurrences all number	4	14	1
FLATULENCE
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences all number	0	2	1
NAUSEA
subjects affected / exposed	2 / 9 (22.22%)	13 / 24 (54.17%)	2 / 3 (66.67%)
occurrences all number	2	19	3
VARICES OESOPHAGEAL
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
VOMITING
subjects affected / exposed	1 / 9 (11.11%)	6 / 24 (25.00%)	1 / 3 (33.33%)
occurrences all number	1	7	1
Hepatobiliary disorders
BILE DUCT STENOSIS
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
HYPERBILIRUBINAEMIA
subjects affected / exposed	2 / 9 (22.22%)	3 / 24 (12.50%)	1 / 3 (33.33%)
occurrences all number	2	3	1
JAUNDICE
subjects affected / exposed	2 / 9 (22.22%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences all number	2	2	1
OCULAR ICTERUS
subjects affected / exposed	2 / 9 (22.22%)	5 / 24 (20.83%)	0 / 3 (0.00%)
occurrences all number	2	5	0
Skin and subcutaneous tissue disorders
PRURITUS
subjects affected / exposed	1 / 9 (11.11%)	7 / 24 (29.17%)	1 / 3 (33.33%)
occurrences all number	1	12	1
PRURITUS GENERALISED
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
RASH
subjects affected / exposed	0 / 9 (0.00%)	7 / 24 (29.17%)	1 / 3 (33.33%)
occurrences all number	0	9	1
RASH GENERALISED
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 9 (11.11%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	2	0
BACK PAIN
subjects affected / exposed	1 / 9 (11.11%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	1	4	0
FISTULA
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
MUSCLE SPASMS
subjects affected / exposed	0 / 9 (0.00%)	6 / 24 (25.00%)	0 / 3 (0.00%)
occurrences all number	0	6	0
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
Infections and infestations
CYSTITIS
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
DIVERTICULITIS
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
FUNGAL INFECTION
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
GASTROENTERITIS
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences all number	0	1	1
NASOPHARYNGITIS
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	0 / 3 (0.00%)
occurrences all number	0	2	0
SOFT TISSUE INFECTION
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
STAPHYLOCOCCAL INFECTION
subjects affected / exposed	0 / 9 (0.00%)	1 / 24 (4.17%)	1 / 3 (33.33%)
occurrences all number	0	1	1
URINARY TRACT INFECTION
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences all number	0	2	1
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	0 / 9 (0.00%)	5 / 24 (20.83%)	0 / 3 (0.00%)
occurrences all number	0	5	0
HYPERKALAEMIA
subjects affected / exposed	0 / 9 (0.00%)	2 / 24 (8.33%)	1 / 3 (33.33%)
occurrences all number	0	2	3
HYPERURICAEMIA
subjects affected / exposed	0 / 9 (0.00%)	0 / 24 (0.00%)	1 / 3 (33.33%)
occurrences all number	0	0	1
HYPOKALAEMIA
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	1 / 3 (33.33%)
occurrences all number	0	6	2
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 9 (0.00%)	3 / 24 (12.50%)	0 / 3 (0.00%)
occurrences all number	0	4	0
HYPONATRAEMIA
subjects affected / exposed	1 / 9 (11.11%)	7 / 24 (29.17%)	1 / 3 (33.33%)
occurrences all number	1	7	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

30 Jun 2014

The purpose of the amendment was to incorporate the changes summarized in the following text: ● Amended the study title by adding the branded name of "TURQUOISE-CPB." ● Amended inclusion criterion number 2 to specify that estrogen-containing contraceptives were not permitted. ● Amended the prohibited meds table in Exclusion criterion 4 to include estrogen containing medications for systemic use. ● Amended exclusion criterion number 10 for abnormal laboratory value for calculated creatinine clearance (by Cockcroft-Gault formula) to be ≤ 50 mL/min. ● Amended exclusion criterion number 15 to clarify that subjects were to be excluded in the event subjects had a confirmed presence of HCC at Screening. ● Modified the treatment period study activities table by adding the following: Child-Pugh Assessment and Score at Premature Discontinuation; liver ultrasound to be performed at Treatment Week 24; and removed the assessment of clinical outcomes at Treatment Day 1. ● Removed the reference to creatinine clearance values for RBV dosing. ● Updated the reference section for ombitasvir, paritaprevir, and dasabuvir Investigator Brochures.

10 Oct 2014

The purpose of the amendment was to incorporate the changes summarized in the following text: ● Updated the study title by removing the word “randomized”. ● Updated the Introduction. ● Amended the study design and treatment based on regulatory feedback. ● Updated sections impacted by the change in study design. ● Updated the number of subjects in the sentinel cohort. ● Revised the amount and format of data to be reviewed from the sentinel cohort. ● Revised rescreening text. ● Amended the RBV total daily dose to reflect that a subject may be initiated at a lower total daily dose upon approval. ● Amended inclusion criterion number 2 to remove the example of "topical" estrogen-containing hormonal contraceptive. ● Amended exclusion criterion number 3 to remove the method used to confirm human immunodeficiency virus (HIV)-1 and HIV-2 infections. ● Amended exclusion criterion number 9 to reflect exclusion of subjects with MELD > 18 at time of screening. ● Amended the Study Activities Table for the Treatment Period to provide additional visits for subjects receiving 24 weeks of treatment; to amend protocol procedures; to update the table footnotes. ● Amended the Study Activities Table for the Post-Treatment Period to include clinical laboratory testing at Post-Treatment Weeks 2 and 8; and to update footnotes. ● Amended the Informed Consent and RBV Information language in Study Procedures to remove the requirement to provide male subjects with an additional RBV Medication Guide and Partner Risk Fact Sheet for female partners. ● Amended the pregnancy testing requirements to only include women of childbearing potential. ● Updated treatment adjustment criteria to align with study design change. ● Amended the ALT Toxicity Management section. ● Added Subsection 6.7.6 "Increase in Child-Pugh Score." ● Updated the "AE Reporting" section to reflect the central back-up number when the SDP was unavailable. ● Updated the Reference section.

03 Mar 2015

● Updated the study title and add central backup contact information, and updated the information. ● Updated the synopsis. ● Updated the list of abbreviations. ● Allowed inclusion of HCV genotype 4 (GT4) population and make appropriate updates through the protocol to reflect this addition. ● Updated the introduction (Section 1.0), differences statement, and benefits/risks. ● Expanded the primary and secondary objectives. ● Revised inclusion criterion number 4. ● Revised exclusion criterion number 4. ● Revised exclusion criterion number 10. ● Amended the study design and treatment. ● Updated the study sample size. ● Updated the list of prohibited therapy. ● Revised the efficacy, pharmacokinetic, pharmacogenetic, and safety assessments/variables. ● Updated the sentinel cohort data review. ● Updated the treatments administered and specific dosing. ● Updated the method of assigning subjects to treatment and randomization methods. ● Amended study drug accountability documentation and study drug return requirements. ● Amended management of creatinine clearance and decreases in hemoglobin. ● Updated contacts for protocol deviations reporting. ● Updated statistical methods and sample size. ● Updated additional efficacy endpoints. ● Updated references. ● Minor clerical updates made throughout the document.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentages of Subjects with Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2

Primary: Percentages of Subjects with Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2

Secondary: Percentage of Subjects With SVR12 in Group 3

Secondary: Percentage of Subjects With SVR12 in Group 3

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing Relapse˅12

Secondary: Percentage of Subjects With SVR12 Non-Response Due to Experiencing Relapse˅12

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Child-Pugh Score

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Child-Pugh Score

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score

Secondary: Percentage of Subjects With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA