Hepatitis C Virus InfectionPhase 2NCT02378935

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

A Phase 2 study testing VOX, SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 34 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: VOX, SOF/VEL and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 34 sitesin 3 countries
Study dates: 17 Feb 2015to 12 Apr 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals with chronic HCV infection
HCV RNA ≥10^4 IU/mL at screening
HCV genotype 1
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two contraception methods if female of childbearing potential or sexually active male

Who cannot join

Pregnant or nursing female
Current or prior history of hepatic decompensation
Hepatocellular carcinoma (HCC) or other clinically significant malignancy
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

34 sites in 3 countries.

Country

City, postcode or hospital

34 sites in 3 countries

United States31 sites

Center for Hep C/Atlanta Medical Center
Atlanta, Georgia
Beth Isreal Deconess Medical Center
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
University of Chicago
Chicago, Illinois
University of Colorado
Denver, Colorado
Henry Ford Hospital and Health System
Detroit, Michigan
Cumberland Research Associates, LLC
Fayetteville, North Carolina
Gastro One
Germantown, Tennessee
ID Care
Hillsborough, New Jersey
Indiana University
Indianapolis, Indiana
Indianapolis Gastroenterology & Hepatology, Inc.
Indianapolis, Indiana
Borland-Groover Clinic
Jacksonville, Florida
Cedars Sinai Medical Center
Los Angeles, California
North Shore/Long Island Jewish PRIME
Manhasset, New York
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia
University of Miami
Miami, Florida
Nashville Gastrointestinal Specialists, Inc.
Nashville, Tennessee
Mount Sinai Beth Israel
New York, New York
Orlando Immunology center
Orlando, Florida
Stanford University
Palo Alto, California
Huntington Memorial Hospital Liver Center
Pasadena, California
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania
Liver Institute of Virginia
Richmond, Virginia
Texas Liver Institute
San Antonio, Texas
Medical Associates Research Group, Inc.
San Diego, California
Southwest Care Center
Santa Fe, New Mexico
Swedish Medical Center
Seattle, Washington
South Florida Center of Gastroenterology, P.A.
Wellington, Florida
Digestive Health Specialists, PA
Winston-Salem, North Carolina

Other trials in United States

New Zealand2 sites

Auckland Clinical Studies
Auckland
Christchurch Clinical Studies Trust
Christchurch

Other trials in New Zealand

Puerto Rico1 site

Fundacion de Investigacion de Diego
San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection

Conditions: Hepatitis C Virus Infection
Being tested: VOX, SOF/VEL, RBV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VOXDrug
Also called GS-9857
100 mg tablet(s) administered orally once daily with food
SOF/VELDrug
Also called GS-7977/GS-5816, Epclusa®
400/100 mg FDC tablet administered orally once daily with food
RBVDrug
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT02378935
Study group	Role	What they receive
VOX+SOF/VEL 6 wk, TN, without cirrhosis	Experimental	VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 8 wk, TN, without cirrhosis	Experimental	VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 6 wk, TN, with cirrhosis	Experimental	VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 8 wk, TN, with cirrhosis	Experimental	VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis	Experimental	VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL; Drug: RBV
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis	Experimental	VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis	Experimental	VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis	Experimental	GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis	Experimental	GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL
VOX+SOF/VEL 12 wk (GS-US-338-1121)	Experimental	VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study) Receives: Drug: VOX; Drug: SOF/VEL

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 12 Weeks

Secondary outcomes (4)

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Measured: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
- On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), 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)
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 201512 Apr 2016

First posted4 Mar 2015 (estimated)
Study start17 Feb 2015
Primary completion1 Feb 2016
Study completion12 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02378935
Sponsor's protocol ID: GS-US-367-1168
Status last verified: Nov 2017
First submitted: 27 Feb 2015
Last updated: 6 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):893-901.e1. doi: 10.1053/j.gastro.2016.07.039. Epub 2016 Jul 30.
PubMed 27486034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection
ClinicalTrials.gov ID: NCT02378935
Acronym / sponsor ID: GS-US-367-1168
Conditions: Hepatitis C Virus Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 17 Feb 2015 (actual)
Primary completion: 1 Feb 2016 (actual)
Study completion: 12 Apr 2016 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Posted 8 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
VOX+SOF/VEL 6 wk, TN, without cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
VOX+SOF/VEL 8 wk, TN, without cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
VOX+SOF/VEL 6 wk, TN, with cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, TN, with cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis	Experimental	Drug: VOX, Drug: SOF/VEL, Drug: RBVVOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis	Experimental	Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
VOX+SOF/VEL 12 wk (GS-US-338-1121)	Experimental	Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Individuals with chronic HCV infection
HCV RNA ≥10^4 IU/mL at screening
HCV genotype 1
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds

Key exclusion criteria (6 listed)

Pregnant or nursing female
Current or prior history of hepatic decompensation
Hepatocellular carcinoma (HCC) or other clinically significant malignancy
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VOXAlso: GS-9857100 mg tablet(s) administered orally once daily with food	Drug	VOX+SOF/VEL 12 wk (GS-US-338-1121), VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis, VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis, VOX+SOF/VEL 6 wk, TN, with cirrhosis, VOX+SOF/VEL 6 wk, TN, without cirrhosis, VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis, VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis, VOX+SOF/VEL 8 wk, TN, with cirrhosis, VOX+SOF/VEL 8 wk, TN, without cirrhosis, VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
SOF/VELAlso: GS-7977/GS-5816, Epclusa®400/100 mg FDC tablet administered orally once daily with food	Drug	VOX+SOF/VEL 12 wk (GS-US-338-1121), VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis, VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis, VOX+SOF/VEL 6 wk, TN, with cirrhosis, VOX+SOF/VEL 6 wk, TN, without cirrhosis, VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis, VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis, VOX+SOF/VEL 8 wk, TN, with cirrhosis, VOX+SOF/VEL 8 wk, TN, without cirrhosis, VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
RBVTablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 Weeks

4 secondary outcomes

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 8 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	34	24
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic	36	36
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	33	30
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic	31	25
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic	31	31
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic	32	32
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)	8	8

Primary outcome: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: Posttreatment Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic n = 34	VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic n = 36	VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic n = 33	VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic n = 31	VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic n = 31	VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic n = 32	VOX+SOF/VEL 12 Weeks (GS-US-338-1121) n = 8
Value	70.6 (52.5 to 84.9)	100.0 (90.3 to 100.0)	93.9 (79.8 to 99.3)	80.6 (62.5 to 92.5)	100 (88.8 to 100.0)	100.0 (89.1 to 100.0)	100.0 (63.1 to 100.0)

Population analysed: Full Analysis Set (FAS): participants who received at least 1 dose of study drug

Primary outcome: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 12 Weeks. Number. Unit: percentage of participants

Measure	VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic n = 34	VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic n = 36	VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic n = 33	VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic n = 31	VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic n = 31	VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic n = 32	VOX+SOF/VEL 12 Weeks (GS-US-338-1121) n = 8
Value	0	0	0	6.5	0	0	0

Population analysed: Safety Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic	0 of 34 (0%)	21 of 34 (61.8%)	0 of 34
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic	0 of 36 (0%)	20 of 36 (55.6%)	0 of 36
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic	2 of 33 (6.1%)	18 of 33 (54.5%)	0 of 33
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic	0 of 31 (0%)	24 of 31 (77.4%)	0 of 31
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic	0 of 31 (0%)	15 of 31 (48.4%)	0 of 31
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic	0 of 32 (0%)	16 of 32 (50%)	0 of 32
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)	0 of 8 (0%)	6 of 8 (75%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27486034Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):893-901.e1. doi: 10.1053/j.gastro.2016.07.039. Epub 2016 Jul 30.
Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

34 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VOX, SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 34 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, New Zealand, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02378935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.