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Chronic HCV InfectionPhase 3NCT02021643

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

A Phase 3 study testing Sofosbuvir, RBV and PEG in people with Chronic HCV Infection, run by Gilead Sciences at 35 sites in 5 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

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic HCV Infection
What is being tested?
Sofosbuvir, RBV and PEG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
687 participants
Where
35 sitesin 5 countries
Study dates
10 Dec 2013to 3 Nov 2016
Phase
Phase 3
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

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with medical records that include sufficient detail of prior treatment with IFN to allow for categorization of prior response as either IFN Intolerant, non-responder, or experiences viral breakthrough or relapse
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Who cannot join

  • Current or prior history of any clinically-significant illness (other than HCV)
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

China17 sites

  • Study site

    Beijing

  • Study site

    Chongqing

  • Study site

    Fujian

  • Study site

    Guangdong

  • Study site

    Guangxi

  • Study site

    Hainan

  • Study site

    Hebei

  • Study site

    Hubei

  • Study site

    Hunan

  • Study site

    Jiangxi

  • Study site

    Jilin City

  • Study site

    Jin’an

  • Study site

    Liaoyang

  • Study site

    Shanghai

  • Study site

    Sichuan

  • Study site

    Yunnan

  • Study site

    Zhejiang

Other trials in China

South Korea7 sites

  • Study site

    Ansan-si

  • Study site

    Bucheon-si

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Incheon, Gyeonggi-do

  • Study site

    Seongnam-si, Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Taiwan7 sites

  • Study site

    Chang-hua

  • Study site

    Kaohsiung City

  • Study site

    Keelung

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Shatin

Other trials in Hong Kong

Vietnam2 sites

  • Study site

    Hanoi

  • Study site

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Being tested
Sofosbuvir, RBV, PEG

What participants receive

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

  • SofosbuvirDrug

    Also called Sovaldi®, GS-7977, PSI-7977

    Sofosbuvir 400 mg tablet administered orally once daily

  • RBVDrug

    Also called Ribasphere®

    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

  • PEGDrug

    Also called Pegasys®

    Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Study groups in NCT02021643
Study groupRoleWhat they receive
Sofosbuvir+RBV+PEG 12 weeksExperimentalParticipants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV; Drug: PEG
Sofosbuvir+RBV 12 weeksExperimentalParticipants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV
Sofosbuvir+RBV 16 weeksExperimentalParticipants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV
Sofosbuvir+RBV 24 WeeksExperimentalParticipants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Measured: Up to 24 weeks

Secondary outcomes (4)

  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With On-Treatment Virologic Failure

    Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.

    Measured: Up to 24 weeks

  3. Percentage of Participants With Viral Relapse

    Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

    Measured: Up to Posttreatment Week 24

  4. Change From Baseline in HCV RNA (log10 IU/mL)

    Measured: Up to 24 weeks

Timeline

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

  1. First posted27 Dec 2013 (estimated)
  2. Study start10 Dec 2013
  3. Primary completion12 Aug 2016
  4. Study completion3 Nov 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02021643
Sponsor's protocol ID
GS-US-334-0115
Status last verified
Aug 2017
First submitted
26 Nov 2013
Last updated
20 Feb 2018
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Lai CL, Wong VW, Yuen MF, Yang JC, Knox SJ, Mo H, Han LL, Brainard DM, Chan HL. Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong. Aliment Pharmacol Ther. 2016 Jan;43(1):96-101. doi: 10.1111/apt.13429. Epub 2015 Oct 26.

    PubMed 26503414

  • Ahn SH, Lim YS, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Mathias A, Han L, Knox SJ, Brainard DM, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus. J Viral Hepat. 2016 May;23(5):358-65. doi: 10.1111/jvh.12499. Epub 2016 Feb 10.

    PubMed 26864153

  • Kao JH, Chien RN, Chang TT, Peng CY, Hu TH, Lo GH, Wang HY, Chen JJ, Yang JC, Knox SJ, Han L, Mo H, Mathias A, Brainard DM, Sheen IS, Hsu YC, Chu CJ, Chuang WL. A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver Int. 2016 Aug;36(8):1101-7. doi: 10.1111/liv.13082. Epub 2016 Mar 23.

    PubMed 26835876

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir, RBV and PEG in people with Chronic HCV Infection, run by Gilead Sciences at 35 sites in 5 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 4 inclusion and 5 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China, South Korea, Taiwan, Hong Kong, Vietnam. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Feb 2018). 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 NCT02021643, which also lists 3 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 20 Feb 2018.

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