Hepatitis CPhase 2NCT01909804

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

A Phase 2 study testing SOF, VEL and RBV in people with Hepatitis C, run by Gilead Sciences at 49 sites in 4 countries.

Completed

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

Trial summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 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
What is being tested?: 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: 323 participants
Where: 49 sitesin 4 countries
Study dates: Jun 2013to Aug 2014
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

Body mass index (BMI) ≥ 18 kg/m^2
HCV RNA ≥ 10000 IU/mL at screening
Prior treatment failure to a regimen including interferon with or without RBV
HCV genotype 1 or 3
Chronic HCV infection
Cirrhosis determination
Use of highly effective contraception methods if female of childbearing potential or sexually active male

Who cannot join

Current or prior history of clinically significant illness other than HCV
Screening ECG with clinically significant abnormalities
Prior exposure to HCV specific direct acting antiviral agent
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of non-HCV etiology
Hepatitis B
Active drug abuse
Use of any prohibited concomitant medications

Trial locations and contacts

49 sites in 4 countries.

Country

City, postcode or hospital

49 sites in 4 countries

United States40 sites

Study site
Annandale, Virginia
Study site
Arlington, Texas
Study site
Asheville, North Carolina
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Fairfax, Virginia
Study site
Fayetteville, North Carolina
Study site
Gainesville, Florida
Study site
Germantown, Tennessee
Study site
Great Neck, New York
Study site
Hillsborough, New Jersey
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Marietta, Georgia
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newport News, Virginia
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Pasadena, California
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
San Antonio, Texas
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San Diego, California
Study site
Santa Fe, New Mexico
Study site
Seattle, Washington
Study site
Tampa, Florida
Study site
Wellington, Florida
Study site
Winston-Salem, North Carolina

Other trials in United States

Australia6 sites

Study site
Camperdown, New South Wales
Study site
Clayton, Victoria
Study site
Darlinghurst, New South Wales
Study site
Fremantle, Western Australia
Study site
Melbourne, Victoria
Study site
Perth, Western Australia

Other trials in Australia

New Zealand2 sites

Study site
Auckland
Study site
Christchurch

Other trials in New Zealand

Puerto Rico1 site

Study site
San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

Conditions: Hepatitis C
Being tested: SOF, VEL, RBV
Keywords: Hepatitis, Genotype 1, Genotype 3, Treatment experienced
Medical subject headings: Hepatitis C, Hepatitis

What participants receive

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

SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
400 mg tablet administered orally once daily
VELDrug
Also called GS-5816
Tablet administered orally once daily
RBVDrug
Also called Ribasphere®
200 mg 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 NCT01909804
Study group	Role	What they receive
SOF+VEL 25 mg (GT3) without cirrhosis	Experimental	Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks. Receives: Drug: SOF
SOF+VEL 25mg+RBV (GT3) without cirrhosis	Experimental	Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 100 mg (GT3) without cirrhosis	Experimental	Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg+RBV (GT3) without cirrhosis	Experimental	Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 25 mg (GT3) with cirrhosis	Experimental	Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg+RBV (GT3) with cirrhosis	Experimental	Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: RBV
SOF+VEL 100 mg (GT3) with cirrhosis	Experimental	Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg+RBV (GT3) with cirrhosis	Experimental	Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 25 mg (GT1)	Experimental	Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg+RBV (GT1)	Experimental	Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 100 mg (GT1)	Experimental	Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg+RBV (GT1)	Experimental	Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks. Receives: Drug: SOF; Drug: VEL; Drug: RBV

What is being measured

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

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping 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 (2)

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
- 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.

Jun 2013Aug 2014

First posted29 Jul 2013 (estimated)
Study startJun 2013
Primary completionMay 2014
Study completionAug 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01909804
Sponsor's protocol ID: GS-US-342-0109
Status last verified: Jul 2016
First submitted: 17 Jul 2013
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 http://www.gilead.com/research/disclosure-and-transparency.

Publications

Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.
Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):809-17. doi: 10.7326/M15-1014. Epub 2015 Nov 10.
PubMed 26551263

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
ClinicalTrials.gov ID: NCT01909804
Acronym / sponsor ID: GS-US-342-0109
Conditions: Hepatitis C
Keywords: Hepatitis, Genotype 1, Genotype 3, Treatment experienced
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: May 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Posted 16 Sep 2016

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
SOF+VEL 25 mg (GT3) without cirrhosis	Experimental	Drug: SOFParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25mg+RBV (GT3) without cirrhosis	Experimental	Drug: SOF, Drug: VEL, Drug: RBVParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT3) without cirrhosis	Experimental	Drug: SOF, Drug: VELParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT3) without cirrhosis	Experimental	Drug: SOF, Drug: VEL, Drug: RBVParticipants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
SOF+VEL 25 mg (GT3) with cirrhosis	Experimental	Drug: SOF, Drug: VELParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25 mg+RBV (GT3) with cirrhosis	Experimental	Drug: SOF, Drug: RBVParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT3) with cirrhosis	Experimental	Drug: SOF, Drug: VELParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT3) with cirrhosis	Experimental	Drug: SOF, Drug: VEL, Drug: RBVParticipants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
SOF+VEL 25 mg (GT1)	Experimental	Drug: SOF, Drug: VELParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
SOF+VEL 25 mg+RBV (GT1)	Experimental	Drug: SOF, Drug: VEL, Drug: RBVParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
SOF+VEL 100 mg (GT1)	Experimental	Drug: SOF, Drug: VELParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
SOF+VEL 100 mg+RBV (GT1)	Experimental	Drug: SOF, Drug: VEL, Drug: RBVParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Who may qualify

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

Key inclusion criteria (7 listed)

Body mass index (BMI) ≥ 18 kg/m^2
HCV RNA ≥ 10000 IU/mL at screening
Prior treatment failure to a regimen including interferon with or without RBV
HCV genotype 1 or 3
Chronic HCV infection

Key exclusion criteria (8 listed)

Current or prior history of clinically significant illness other than HCV
Screening ECG with clinically significant abnormalities
Prior exposure to HCV specific direct acting antiviral agent
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of non-HCV etiology

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
SOFAlso: Sovaldi®, GS-7977, PSI-7977400 mg tablet administered orally once daily	Drug	SOF+VEL 100 mg (GT1), SOF+VEL 100 mg (GT3) with cirrhosis, SOF+VEL 100 mg (GT3) without cirrhosis, SOF+VEL 100 mg+RBV (GT1), SOF+VEL 100 mg+RBV (GT3) with cirrhosis, SOF+VEL 100 mg+RBV (GT3) without cirrhosis, SOF+VEL 25 mg (GT1), SOF+VEL 25 mg (GT3) with cirrhosis, SOF+VEL 25 mg (GT3) without cirrhosis, SOF+VEL 25 mg+RBV (GT1), SOF+VEL 25 mg+RBV (GT3) with cirrhosis, SOF+VEL 25mg+RBV (GT3) without cirrhosis
VELAlso: GS-5816Tablet administered orally once daily	Drug	SOF+VEL 100 mg (GT1), SOF+VEL 100 mg (GT3) with cirrhosis, SOF+VEL 100 mg (GT3) without cirrhosis, SOF+VEL 100 mg+RBV (GT1), SOF+VEL 100 mg+RBV (GT3) with cirrhosis, SOF+VEL 100 mg+RBV (GT3) without cirrhosis, SOF+VEL 25 mg (GT1), SOF+VEL 25 mg (GT3) with cirrhosis, SOF+VEL 25 mg+RBV (GT1), SOF+VEL 25mg+RBV (GT3) without cirrhosis
RBVAlso: Ribasphere®200 mg 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)	Drug	SOF+VEL 100 mg+RBV (GT1), SOF+VEL 100 mg+RBV (GT3) with cirrhosis, SOF+VEL 100 mg+RBV (GT3) without cirrhosis, SOF+VEL 25 mg+RBV (GT1), SOF+VEL 25 mg+RBV (GT3) with cirrhosis, SOF+VEL 25mg+RBV (GT3) without cirrhosis

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks

2 secondary outcomes

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 16 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SOF+VEL 25 mg (GT3 Non-Cirrhotic)	26	22
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)	28	27
SOF+VEL 100 mg (GT3 Non-Cirrhotic)	27	27
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)	26	26
SOF+VEL 25 mg (GT3 Cirrhotic)	26	18
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)	25	21
SOF+VEL 100 mg (GT3 Cirrhotic)	27	25
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)	26	25
SOF+VEL 25 mg (GT1)	27	27
SOF+VEL 25 mg + RBV (GT1)	29	28
SOF+VEL 100 mg (GT1)	27	26
SOF+VEL 100 mg + RBV (GT1)	29	26

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

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

Measure	SOF+VEL 25 mg (GT3 Non-Cirrhotic) n = 26	SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic) n = 28	SOF+VEL 100 mg (GT3 Non-Cirrhotic) n = 27	SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic) n = 26	SOF+VEL 25 mg (GT3 Cirrhotic) n = 26	SOF+VEL 25 mg + RBV (GT3 Cirrhotic) n = 25	SOF+VEL 100 mg (GT3 Cirrhotic) n = 26	SOF+VEL 100 mg + RBV (GT3 Cirrhotic) n = 26	SOF+VEL 25 mg (GT1) n = 27	SOF+VEL 25 mg + RBV (GT1) n = 29	SOF+VEL 100 mg (GT1) n = 27	SOF+VEL 100 mg + RBV (GT1) n = 28
Value	84.6 (65.1 to 95.6)	96.4 (81.7 to 99.9)	100.0 (87.2 to 100.0)	100.0 (86.8 to 100.0)	57.7 (36.9 to 76.6)	84.0 (63.9 to 95.5)	88.5 (69.8 to 97.6)	96.2 (80.4 to 99.9)	100.0 (87.2 to 100.0)	96.6 (82.2 to 99.9)	100.0 (87.2 to 100.0)	96.4 (81.7 to 99.9)

Population analysed: Full Analysis Set: participants randomized into the study and 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	SOF+VEL 25 mg n = 79	SOF+VEL 25 mg + RBV n = 82	SOF+VEL 100 mg n = 80	SOF+VEL 100 mg + RBV n = 80
Value	0	1.2	0	0

Population analysed: Safety Analysis Set

2 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
SOF+VEL 25 mg	1 of 79 (1.3%)	54 of 79 (68.4%)	Not reported
SOF+VEL 25 mg + RBV	0 of 82 (0%)	61 of 82 (74.4%)	Not reported
SOF+VEL 100 mg	4 of 80 (5%)	54 of 80 (67.5%)	Not reported
SOF+VEL 100 mg + RBV	3 of 80 (3.8%)	62 of 80 (77.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationPianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.
Results publication: PubMed 26551263Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):809-17. doi: 10.7326/M15-1014. Epub 2015 Nov 10.
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 http://www.gilead.com/research/disclosure-and-transparency.

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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.

John McNally study director

Gilead Sciences

49 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF, VEL and RBV in people with Hepatitis C, run by Gilead Sciences at 49 sites in 4 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 7 inclusion and 8 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Australia, 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 16 Sep 2016). 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 (SVR) 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 NCT01909804, which also lists 2 linked publications.

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 15 Nov 2018.