Hepatitis CPhase 3NCT01910636

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

A Phase 3 study testing Sofosbuvir and RBV in people with Hepatitis C, run by Gilead Sciences at 19 sites in Japan.

Completed

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

Trial summary

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hepatitis C
What is being tested?: Sofosbuvir and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 19 sitesJapan
Study dates: Feb 2013to Jun 2014
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic genotype 2 HCV-infection
Male or female, age ≥ 20 years
Body weight ≥ 40 kg
HCV RNA ≥ 10,000 IU/mL at screening

Who cannot join

Current or prior history of 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)

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Japan19 sites

Study site
Akita
Study site
Chiba
Study site
Chiyoda-ku
Study site
Gifu
Study site
Ichikawa
Study site
Itabashi-ku
Study site
Izunokuni
Study site
Kita-ku
Study site
Kurashiki
Study site
Kurume
Study site
Matsumoto
Study site
Musashino
Study site
Nishinomiya
Study site
Ōgaki
Study site
Ōmura
Study site
Sapporo
Study site
Shinjuku-ku
Study site
Suita
Study site
Yamagata

Other trials in Japan

About this study

Official title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Conditions: Hepatitis C
Being tested: Sofosbuvir, RBV
Keywords: HCV genotype 2 (GT-2)
Medical subject headings: Hepatitis C

What participants receive

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

SofosbuvirDrug
Also called GS-7977, PSI-7977, Sovaldi®
Sofosbuvir 400 mg tablet administered orally once daily
RBVDrug
Also called Copegus®
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Study groups in NCT01910636
Study group	Role	What they receive
Sofosbuvir+RBV 12 weeks	Experimental	Participants will receive sofosbuvir+RBV for 12 weeks. Receives: Drug: Sofosbuvir; 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) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Measured: Up to 12 weeks

Secondary outcomes (3)

Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants Experiencing Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.
Measured: Up to 12 weeks
Percentage of Participants Experiencing Viral Relapse
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
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.

Feb 2013Jun 2014

First posted29 Jul 2013 (estimated)
Study startFeb 2013
Primary completionMar 2014
Study completionJun 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.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910636
Sponsor's protocol ID: GS-US-334-0118
Status last verified: Mar 2015
First submitted: 23 Jul 2013
Last updated: 24 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
ClinicalTrials.gov ID: NCT01910636
Acronym / sponsor ID: GS-US-334-0118
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Mar 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Posted 24 Mar 2015

Clinical summary

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

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sofosbuvir+RBV 12 weeks	Experimental	Drug: Sofosbuvir, Drug: RBVParticipants will receive sofosbuvir+RBV for 12 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chronic genotype 2 HCV-infection
Male or female, age ≥ 20 years
Body weight ≥ 40 kg
HCV RNA ≥ 10,000 IU/mL at screening

Key exclusion criteria (4 listed)

Current or prior history of 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)

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
SofosbuvirAlso: GS-7977, PSI-7977, Sovaldi®Sofosbuvir 400 mg tablet administered orally once daily	Drug	Sofosbuvir+RBV 12 weeks
RBVAlso: Copegus®Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)	Drug	Sofosbuvir+RBV 12 weeks

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) at 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, 25 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time frame: Up to 12 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.

3 secondary outcomes

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants Experiencing Viral Breakthrough
Time frame: Up to 12 weeks
Percentage of Participants Experiencing Viral Relapse
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 24 Mar 2015, 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+RBV Treatment Naive	90	90
SOF+RBV Treatment Experienced	63	63

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

Time frame: Posttreatment Week 12. Number. Unit: percentage of participants

Measure	SOF+RBV Treatment Naive n = 90	SOF+RBV Treatment Experienced n = 63
Value	97.8	95.2

Population analysed: Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.

Primary outcome: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

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

Measure	SOF+RBV n = 153
Value	0

Population analysed: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug

3 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+RBV	2 of 153 (1.3%)	69 of 153 (45.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Steven Knox study director

Gilead Sciences

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir and RBV in people with Hepatitis C, run by Gilead Sciences at 19 sites in Japan.

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 4 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. 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 24 Mar 2015). 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) at 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 NCT01910636.

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 24 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.