Clinical Trial Results:
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection
Summary
|
|
EudraCT number |
2014-003898-42 |
Trial protocol |
GB DE BE IT |
Global end of trial date |
15 Jun 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
18 May 2017
|
First version publication date |
18 May 2017
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
GS-US-342-1446
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02346721 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Gilead Sciences
|
||
Sponsor organisation address |
333 Lakeside Drive, Foster City, CA, United States, 94404
|
||
Public contact |
Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
|
||
Scientific contact |
Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
|
||
Paediatric regulatory details
|
|||
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
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
15 Jun 2016
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
15 Jun 2016
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The primary objectives of this study were to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
|
||
Protection of trial subjects |
The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Feb 2015
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 13
|
||
Country: Number of subjects enrolled |
United States: 42
|
||
Country: Number of subjects enrolled |
Belgium: 4
|
||
Country: Number of subjects enrolled |
Canada: 6
|
||
Country: Number of subjects enrolled |
China: 1
|
||
Country: Number of subjects enrolled |
France: 31
|
||
Country: Number of subjects enrolled |
Germany: 7
|
||
Country: Number of subjects enrolled |
Hong Kong: 3
|
||
Country: Number of subjects enrolled |
Italy: 2
|
||
Country: Number of subjects enrolled |
Puerto Rico: 2
|
||
Worldwide total number of subjects |
111
|
||
EEA total number of subjects |
57
|
||
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) |
100
|
||
From 65 to 84 years |
11
|
||
85 years and over |
0
|
|
|||||||||||||
Recruitment
|
|||||||||||||
Recruitment details |
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 February 2015. The last study visit occurred on 15 June 2016. | ||||||||||||
Pre-assignment
|
|||||||||||||
Screening details |
116 participants were screened. | ||||||||||||
Period 1
|
|||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||
Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Non-randomised - controlled
|
||||||||||||
Blinding used |
Not blinded | ||||||||||||
Arms
|
|||||||||||||
Arm title
|
SOF/VEL 12 Weeks | ||||||||||||
Arm description |
SOF/VEL (400/100 mg) FDC tablet orally once daily | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
SOF/VEL
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
GS-7977/GS-5816, Epclusa®
|
||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||
Routes of administration |
Oral use
|
||||||||||||
Dosage and administration details |
400/100 mg administered once daily
|
||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SOF/VEL 12 Weeks
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
SOF/VEL (400/100 mg) FDC tablet orally once daily | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
SOF/VEL 12 Weeks
|
||
Reporting group description |
SOF/VEL (400/100 mg) FDC tablet orally once daily |
|
|||||||||
End point title |
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [1] | ||||||||
End point description |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. Full Analysis Set (FAS) included all enrolled participants who took at least 1 dose of study drug.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Posttreatment Week 12
|
||||||||
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: No statistical analysis was planned or performed. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2] | ||||||||
End point description |
Safety Analysis Set included participants who took at least 1 dose of study drug.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Up to 12 weeks
|
||||||||
Notes [2] - 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: No statistical analysis was planned or performed. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | ||||||||||||
End point description |
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Full Analysis Set
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Posttreatment Weeks 4 and 24
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||
End point title |
Percentage of Participants With HCV RNA < LLOQ While on Treatment | ||||||||||||||||||||||
End point description |
Participants in the Full Analysis Set with available data were analyzed.
|
||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||
End point timeframe |
Baseline to Week 12
|
||||||||||||||||||||||
|
|||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||
End point title |
HCV RNA Change From Baseline | ||||||||||||||||||||||
End point description |
Participants in the Full Analysis Set with available data were analyzed.
|
||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||
End point timeframe |
Baseline to Week 12
|
||||||||||||||||||||||
|
|||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Percentage of Participants With Virologic Failure | ||||||||
End point description |
1) Virologic failure was defined as:
• On-treatment virologic failure:
o Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
o Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
o Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
• Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
2) Full Analysis Set
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Posttreatment Week 24
|
||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to 12 weeks plus 30 days
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Safety Analysis Set
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SOF/VEL 12 Weeks
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
SOF/VEL (400/100 mg) FDC tablet orally once daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
07 Apr 2015 |
Update to concomitant medications to prohibit the use of amiodarone from 60 days prior to Baseline/Day 1 through the end of treatment due to new safety information |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |