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Clinical Trial Results:
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)

Summary
EudraCT number	2015-002272-24
Trial protocol	DE GB SE
Global end of trial date	06 Feb 2017

Results information
Results version number	v1(current)
This version publication date	15 Nov 2017
First version publication date	15 Nov 2017
Other versions

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

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Trial information

Top of page

Sponsor protocol code

M13-594

ISRCTN number

-

US NCT number

NCT02640157

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

Global Medical Services, AbbVie, 001 800-633-9110,

Scientific contact

Armen Asatryan, AbbVie, armen.asatryan@abbvie.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

06 Feb 2017

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

06 Feb 2017

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study was to demonstrate non-inferiority in the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 to 12 weeks of treatment with Sofosbuvir and Daclatasvir; to demonstrate non-inferiority of 8 weeks of treatment with ABT-493/ABT-530 to 12 weeks of treatment with ABT-493/ABT-530; and to assess safety of ABT-493/ABT-530 compared to Sofosbuvir and Daclatasvir in treatment-naïve adults with chronic hepatitis C virus (HCV) genotype 3 (GT3) infection.

Protection of trial subjects

The investigator or his/her representative explained the nature of the study to the subject, and answered all questions regarding this study. Prior to any study-related screening procedures being performed on the subject, the informed consent statement was reviewed, signed, and dated by the subject.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

13 Nov 2015

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Sweden: 20

Country: Number of subjects enrolled

United Kingdom: 82

Country: Number of subjects enrolled

France: 46

Country: Number of subjects enrolled

Germany: 27

Country: Number of subjects enrolled

Australia: 70

Country: Number of subjects enrolled

Canada: 30

Country: Number of subjects enrolled

United States: 146

Country: Number of subjects enrolled

Switzerland: 41

Country: Number of subjects enrolled

New Zealand: 44

Worldwide total number of subjects

506

EEA total number of subjects

175

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

488

From 65 to 84 years

18

85 years and over

0

Subject disposition

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Recruitment details

Subjects must have been HCV treatment-naïve (i.e., subject had never received any anti-HCV treatment) prior to enrolling in the study.

Screening details

A total of 506 participants were randomized and 505 received ≥ 1 dose of study drug. One participant in Arm B was randomized in error and never dispensed study drug. This study included a 42-day screening period.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Arm A

Arm description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Arm type

Experimental

Investigational medicinal product name

ABT-493/ABT-530

Investigational medicinal product code

Other name

ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVIRET

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Arm B

Arm description

Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Sofosbuvir

Investigational medicinal product code

Other name

Sovaldi

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

400 mg once daily for 12 weeks.

Investigational medicinal product name

Daclatasvir

Investigational medicinal product code

Other name

Daklinza

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60 mg once daily for 12 weeks.

Arm C

Arm description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Arm type

Experimental

Investigational medicinal product name

ABT-493/ABT-530

Investigational medicinal product code

Other name

ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVIRET

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily for 8 weeks.

Number of subjects in period 1 ^[1]	Arm A	Arm B	Arm C
Started	233	115	157
Received study drug	233	115	157
Completed study drug	225	112	154
Discontinued study drug	8 ^[2]	3 ^[3]	3 ^[4]
Completed	220	111	147
Not completed	13	4	10
Consent withdrawn by subject	2	-	2
Adverse event, non-fatal	2	2	1
Lost to follow-up	9	2	7

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 506 participants were enrolled; 1 subject (Arm B) was enrolled in error, was never dispensed study drug, and is excluded from the analysis.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This number refers to study drug disposition and not overall study disposition.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This number refers to study drug disposition and not overall study disposition.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This number refers to study drug disposition and not overall study disposition.

Baseline characteristics

Top of page

Reporting group title

Arm A

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Reporting group title

Arm B

Reporting group description

Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

Reporting group title

Arm C

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Reporting group values	Arm A	Arm B	Arm C	Total
Number of subjects	233	115	157	505
Age categorical
Units: Subjects
Age continuous
Safety population: All participants who received at least one dose of study drug.
Units: years
arithmetic mean (standard deviation)	47.18 ( 10.68 )	47.06 ( 11.31 )	45.43 ( 12.19 )	-
Gender categorical
Units: Subjects
Female	112	63	64	239
Male	121	52	93	266

End points

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Reporting group title

Arm A

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Reporting group title

Arm B

Reporting group description

Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

Reporting group title

Arm C

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Primary: Percentage of Participants With Sustained Virologic Response 12 weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B

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End point title

Percentage of Participants With Sustained Virologic Response 12 weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B ^[1]

End point description

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.

End point type

Primary

End point timeframe

12 weeks after the last actual dose of study drug

Notes
[1] - 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 efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir + daclatasvir). For Arm A, the percentage of subjects (97.5% CI) is 95.3% (92.2, 98.4). See noninferiority criteria a) and c) in Statistical Analyses sections below.

End point values	Arm A	Arm B
Number of subjects analysed	233 ^[2]	115 ^[3]
Units: Percentage of participants
number (confidence interval 95%)	95.3 (92.6 to 98.0)	96.5 (93.2 to 99.9)

Notes
[2] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders
[3] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders

Difference in SVR12 rates (Arm A - Arm B)

Statistical analysis description

Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.

Comparison groups

Arm A v Arm B

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

Parameter type

Difference in percentage of participants

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

3.1

Notes
[4] - Noninferiority criterion a)

Difference in SVR12 rates (Arm A - Arm B)

Statistical analysis description

Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.

Comparison groups

Arm A v Arm B

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[5]

Method

Parameter type

Difference in percentage of participants

Point estimate

-1.2

Confidence interval

level

97.5%

sides

2-sided

lower limit

-6.2

upper limit

3.7

Notes
[5] - Noninferiority criterion c)

Primary: Percentage of Participants With Sustained Virologic Response 12 weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A

Top of page

End point title

Percentage of Participants With Sustained Virologic Response 12 weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A ^[6]

End point description

SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.

End point type

Primary

End point timeframe

12 weeks after the last actual dose of study drug

Notes
[6] - 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: If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. For Arm C, the percentage of subjects (97.5% CI) is 94.9% (91.0, 98.8). See noninferiority criteria a) and c) in Statistical Analyses sections below.

End point values	Arm A	Arm C
Number of subjects analysed	233 ^[7]	157 ^[8]
Units: percentage of participants
number (confidence interval 95%)	95.3 (92.6 to 98.0)	94.9 (91.5 to 98.3)

Notes
[7] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders
[8] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders

Difference in SVR12 rates (Arm C - Arm A)

Statistical analysis description

Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.

Comparison groups

Arm A v Arm C

Number of subjects included in analysis

390

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[9]

Method

Parameter type

Difference in percentage of participants

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-4.8

upper limit

4

Notes
[9] - Noninferiority criterion a)

Noninferiority of Arm C to Arm A

Statistical analysis description

Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.

Comparison groups

Arm A v Arm C

Number of subjects included in analysis

390

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[10]

Method

Parameter type

Difference in percentage of participants

Point estimate

-0.4

Confidence interval

level

97.5%

sides

2-sided

lower limit

-5.4

upper limit

4.6

Notes
[10] - Noninferiority criterion c)

Secondary: Percentage of Participants With Sustained Virologic Response 12 weeks post-treatment (SVR12): Superiority of Arm A to Arm B

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End point title

Percentage of Participants With Sustained Virologic Response 12 weeks post-treatment (SVR12): Superiority of Arm A to Arm B ^[11]

End point description

SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.

End point type

Secondary

End point timeframe

12 weeks after the last actual dose of study drug

Notes
[11] - 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 endpoint was defined as superiority of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir + daclatasvir).

End point values	Arm A	Arm B
Number of subjects analysed	233 ^[12]	115 ^[13]
Units: percentage of participants
number (confidence interval 95%)	95.3 (92.6 to 98.0)	96.5 (93.2 to 99.9)

Notes
[12] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders
[13] - ITT: subjects rcvd ≥ 1 dose of Tx; missing data after backwards imputation = nonresponders

No statistical analyses for this end point

Secondary: Percentage of participants with on-treatment virologic failure

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End point title

Percentage of participants with on-treatment virologic failure

End point description

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

End point type

Secondary

End point timeframe

Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment

End point values	Arm A	Arm B	Arm C
Number of subjects analysed	233 ^[14]	115 ^[15]	157 ^[16]
Units: percentage of participants
number (confidence interval 95%)	0.4 (0.1 to 2.4)	0 (0.0 to 3.2)	0.6 (0.1 to 3.5)

Notes
[14] - All participants who received at least 1 dose of study drug (ITT population)
[15] - All participants who received at least 1 dose of study drug (ITT population)
[16] - All participants who received at least 1 dose of study drug (ITT population)

No statistical analyses for this end point

Secondary: Percentage of participants with post-treatment relapse

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End point title

Percentage of participants with post-treatment relapse

End point description

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

End point type

Secondary

End point timeframe

From the end of treatment through 12 weeks after the last dose of study drug

End point values	Arm A	Arm B	Arm C
Number of subjects analysed	222 ^[17]	114 ^[18]	150 ^[19]
Units: percentage of participants
number (confidence interval 95%)	1.4 (0.5 to 3.9)	0.9 (0.2 to 4.8)	3.3 (1.4 to 7.6)

Notes
[17] - Subjects rcvd ≥ 1 dose of Tx, completed Tx, and had HCV RNA <LLOQ at the final treatment visit
[18] - Subjects rcvd ≥ 1 dose of Tx, completed Tx, and had HCV RNA <LLOQ at the final treatment visit
[19] - Subjects rcvd ≥ 1 dose of Tx, completed Tx, and had HCV RNA <LLOQ at the final treatment visit

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).

Adverse event reporting additional description

TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Arm A

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Reporting group title

Arm B

Reporting group description

Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks.

Reporting group title

Arm C

Reporting group description

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Serious adverse events	Arm A	Arm B	Arm C
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 233 (2.15%)	2 / 115 (1.74%)	3 / 157 (1.91%)
number of deaths (all causes)	0	1	1
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus and nasal cavity malignant neoplasm recurrent
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	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 / 233 (0.00%)	0 / 115 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Poisoning
subjects affected / exposed	0 / 233 (0.00%)	0 / 115 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion missed
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Ulcerative keratitis
subjects affected / exposed	0 / 233 (0.00%)	0 / 115 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Dependence
subjects affected / exposed	0 / 233 (0.00%)	0 / 115 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Substance-induced psychotic disorder
subjects affected / exposed	0 / 233 (0.00%)	1 / 115 (0.87%)	0 / 157 (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
Ophthalmic herpes simplex
subjects affected / exposed	0 / 233 (0.00%)	0 / 115 (0.00%)	1 / 157 (0.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 233 (0.43%)	0 / 115 (0.00%)	0 / 157 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Iron deficiency
subjects affected / exposed	0 / 233 (0.00%)	1 / 115 (0.87%)	0 / 157 (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

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

Non-serious adverse events	Arm A	Arm B	Arm C
Total subjects affected by non serious adverse events
subjects affected / exposed	126 / 233 (54.08%)	53 / 115 (46.09%)	64 / 157 (40.76%)
Nervous system disorders
Headache
subjects affected / exposed	60 / 233 (25.75%)	21 / 115 (18.26%)	31 / 157 (19.75%)
occurrences all number	64	22	31
General disorders and administration site conditions
Asthenia
subjects affected / exposed	4 / 233 (1.72%)	7 / 115 (6.09%)	3 / 157 (1.91%)
occurrences all number	4	9	4
Fatigue
subjects affected / exposed	44 / 233 (18.88%)	16 / 115 (13.91%)	20 / 157 (12.74%)
occurrences all number	45	16	20
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	15 / 233 (6.44%)	4 / 115 (3.48%)	18 / 157 (11.46%)
occurrences all number	15	5	19
Nausea
subjects affected / exposed	32 / 233 (13.73%)	15 / 115 (13.04%)	19 / 157 (12.10%)
occurrences all number	32	15	20
Vomiting
subjects affected / exposed	10 / 233 (4.29%)	5 / 115 (4.35%)	9 / 157 (5.73%)
occurrences all number	12	5	9
Psychiatric disorders
Insomnia
subjects affected / exposed	9 / 233 (3.86%)	6 / 115 (5.22%)	0 / 157 (0.00%)
occurrences all number	9	6	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	12 / 233 (5.15%)	6 / 115 (5.22%)	4 / 157 (2.55%)
occurrences all number	13	6	4
Upper respiratory tract infection
subjects affected / exposed	15 / 233 (6.44%)	4 / 115 (3.48%)	2 / 157 (1.27%)
occurrences all number	15	4	2

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Were there any global substantial amendments to the protocol? Yes

28 Aug 2015

- Changed the comparator arm regimen from SOF 400 mg QD + RBV 1,000 or 1,200 mg (weight-based total daily dose) for 24 weeks to SOF 400 mg QD + DCV 60 mg QD for 12 weeks. - Made necessary updates throughout the protocol to reflect the change from RBV to DCV in the comparator arm. - Increased the number of subjects to be enrolled from approximately 300 to approximately 345 due to modification of the noninferiority margin as a result of the change in active comparator. - Specified the reflex assay used for determination of HCV genotype/subtype. - Revised Inclusion Criteria 2 and 3 to list birth control options for females of childbearing potential (both female subjects or female partners of male subjects) removed pregnancy precautions due to absence of RBV in the comparator arm. - Updated SAE reporting requirements to include all SAEs that occurred during the Post-Treatment Period regardless of relatedness to study drug. - Revised the analytical method, including decreasing the noninferiority margin for the primary efficacy analysis due to the change of the active comparator. - Revised the key secondary efficacy analysis due to the changes made to the primary efficacy analysis.

01 Oct 2015

- Changed the primary analysis population for the between-arm comparison of efficacy from the per protocol population to the ITT population. - Updated Inclusion Criteria 2 and 3 to require at least 1 effective form of birth control for female subjects of childbearing potential (both female subjects and female partners of male subjects) starting at screening and for 30 days after the last dose of study drug. - Added Appendix C to list effective forms of birth control that were allowed during the study.

09 Oct 2015

- Updated Inclusion Criterion 2 to clarify that female participants in Arm B were to follow contraceptive precautions as per local SOF and DCV labels. - Added a statement to Appendix C to denote highly effective methods of contraception and instances in their use per Clinical Trial Facilitation Group guidance.

29 Jan 2016

- Added an 8-week ABT-493/ABT-530 treatment duration arm. - Added a primary efficacy analysis for the 8-week comparison due to the addition of an 8-week treatment arm. - Added efficacy analysis details specific to the added 8-week treatment arm. - Added baseline creatinine clearance and estimated glomerular filtration rate (eGFR) to the list of efficacy subgroup variables. - Modified the sample size due to the addition of the 8-week treatment arm. - The PRO analysis on the cumulative number of subjects who have ever experienced an increase from baseline was updated to align across the ABT-493/ABT-530 program.

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

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