Clinical Trial Results:
An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Summary
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EudraCT number |
2017-000179-98 |
Trial protocol |
GB |
Global end of trial date |
19 Mar 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Mar 2019
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First version publication date |
24 Mar 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS-US-367-4181
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03118843 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Gilead Sciences
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Sponsor organisation address |
333 Lakeside Drive, Foster City, CA , United States, 94404
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Public contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Scientific contact |
Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Mar 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Mar 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Mar 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV)
infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Apr 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
New Zealand: 3
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Country: Number of subjects enrolled |
Canada: 2
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Country: Number of subjects enrolled |
United States: 20
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Country: Number of subjects enrolled |
Australia: 2
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Country: Number of subjects enrolled |
France: 1
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Country: Number of subjects enrolled |
Germany: 2
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Worldwide total number of subjects |
31
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EEA total number of subjects |
4
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018. | ||||||
Pre-assignment
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Screening details |
38 participants were screened. | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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SOF/VEL/VOX | ||||||
Arm description |
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Sofosbuvir/velpatasvir/voxilaprevir
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Investigational medicinal product code |
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Other name |
SOF/VEL/VOX, Vosevi®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
400/100/100 mg FDC tablet administered orally once daily with food
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Baseline characteristics reporting groups
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Reporting group title |
SOF/VEL/VOX
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Reporting group description |
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
SOF/VEL/VOX
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Reporting group description |
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks |
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End point title |
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1] | ||||||||
End point description |
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.
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End point type |
Primary
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End point timeframe |
Posttreatment Week 12
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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 comparison was planned or performed. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2] | ||||||||
End point description |
Participants in the Safety Analysis Set were analyzed.
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End point type |
Primary
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End point timeframe |
Up to Week 12
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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 comparison was planned or performed. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | ||||||||
End point description |
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
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End point type |
Secondary
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End point timeframe |
Posttreatment Week 4
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With HCV RNA < LLOQ On Treatment | ||||||||||||||||
End point description |
Participants in the Full Analysis Set were analyzed.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 4, 8, and 12
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With Virologic Failure | ||||||||
End point description |
Virologic failure was defined as:
1) On-treatment virologic failure:
• Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), or
• Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
• Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
2) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Participants in the Full Analysis Set were analyzed.
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End point type |
Secondary
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End point timeframe |
Up to Posttreatment Week 12
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No statistical analyses for this end point |
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End point title |
Change From Baseline in HCV RNA | ||||||||||||||||
End point description |
Participants in the Full Analysis Set with available data were analyzed.
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End point type |
Secondary
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End point timeframe |
Baseline; Weeks 2, 4, 8, and 12
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
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Adverse event reporting additional description |
Safety Analysis Set included all participants who took at least 1 dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
SOF/VEL/VOX
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Reporting group description |
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |