Hepatitis CPhase 3NCT01896193

Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection

A Phase 3 study testing SOF and RBV in people with Hepatitis C, run by Gilead Sciences at 16 sites in Russia.

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 plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) 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 and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 16 sitesRussia
Study dates: Jun 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed chronic genotype 1 or 3 HCV infection
HCV treatment-naive
Individuals will have cirrhosis status assessment; liver biopsy may be required.
Screening laboratory values within predefined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Who cannot join

Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contraindication to ribavirin therapy
Excessive alcohol ingestion as defined by protocol
History of solid organ transplantation
Current or prior history of clinical hepatic decompensation
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Russia16 sites

Central Clinical Hospital of the Russian Academy of Sciences
Moscow
Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
Moscow
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
Moscow
City Clinical Hospital 24
Moscow
Clinical Diagnostics and Research Center of Federal Bedgetary Institution
Moscow
Infectious Clinical Hospital No. 1
Moscow
Institute of Nutrition of Academy of Sciences
Moscow
Institution of Healthcare of Sverdlovsk Region
Moscow
Institution of High Professional Education First Moscow State Medical University
Moscow
Institution of Tumen Region
Moscow
Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Moscow
Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow
Moscow
Stavropol State Medical University of Ministry of Healthcare
Moscow
Medical Military Academy n.a. S.M. Kirov
Saint Petersburg
Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg
Medical Company Hepatolog
Samara

Other trials in Russia

About this study

Official title: A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.

Conditions: Hepatitis C
Being tested: SOF, 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.

SOFDrug
Also called Sovaldi®, PSI-7977, GS-7977
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVDrug
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT01896193
Study group	Role	What they receive
SOF+RBV 16 Weeks	Experimental	SOF+RBV for 16 weeks Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 Weeks	Experimental	SOF+RBV for 24 weeks Receives: Drug: SOF; 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 24 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 On-treatment Virologic Failure
On-treatment virologic failure was defined as
- 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)
Measured: Up to 24 weeks
Percentage of Participants Experiencing Virologic Relapse
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 12

Timeline

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

Jun 2013Jun 2014

First posted11 Jul 2013 (estimated)
Study startJun 2013
Primary completionApr 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.
Publications (1)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01896193
Sponsor's protocol ID: GS-US-334-0119
Status last verified: May 2015
First submitted: 2 Jul 2013
Last updated: 29 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.
PubMed 27376706

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 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.
ClinicalTrials.gov ID: NCT01896193
Acronym / sponsor ID: GS-US-334-0119
Conditions: Hepatitis C
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Apr 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 11 Jul 2013 (estimated)
Results: Posted 17 Apr 2015

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: 2

Arm	Type	Receives
SOF+RBV 16 Weeks	Experimental	Drug: SOF, Drug: RBVSOF+RBV for 16 weeks
SOF+RBV 24 Weeks	Experimental	Drug: SOF, Drug: RBVSOF+RBV for 24 weeks

Who may qualify

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

Key inclusion criteria (5 listed)

Confirmed chronic genotype 1 or 3 HCV infection
HCV treatment-naive
Individuals will have cirrhosis status assessment; liver biopsy may be required.
Screening laboratory values within predefined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Key exclusion criteria (7 listed)

Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contraindication to ribavirin therapy
Excessive alcohol ingestion as defined by protocol
History of solid organ transplantation

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®, PSI-7977, GS-7977Sofosbuvir (SOF) 400 mg tablet administered orally once daily	Drug	SOF+RBV 16 Weeks, SOF+RBV 24 Weeks
RBVRibavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	SOF+RBV 16 Weeks, SOF+RBV 24 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 24 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 On-treatment Virologic Failure
Time frame: Up to 24 weeks
Percentage of Participants Experiencing Virologic Relapse
Time frame: Up to Posttreatment Week 12

Results and safety

Results posted to the registry on 17 Apr 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 16 Weeks	62	41
SOF+RBV 24 Weeks	65	53

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 16 Weeks, GT1 n = 32	SOF+RBV 24 Weeks, GT1 n = 34	SOF+RBV 16 Weeks, GT3 n = 30	SOF+RBV 24 Weeks, GT3 n = 31
Value	50.0	76.5	86.7	90.3

Population analysed: Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug

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

Time frame: Up to 24 weeks. Number. Unit: percentage of participants

Measure	SOF+RBV 16 Weeks, GT1 n = 32	SOF+RBV 24 Weeks, GT1 n = 34	SOF+RBV 16 Weeks, GT3 n = 30	SOF+RBV 24 Weeks, GT3 n = 31
Value	0	0	0	0

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOF+RBV 16 Weeks	1 of 62 (1.6%)	16 of 62 (25.8%)	Not reported
SOF+RBV 24 Weeks	1 of 65 (1.5%)	21 of 65 (32.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27376706Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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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.

Kathryn Kersey, MSc study director

Gilead Sciences

16 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 SOF and RBV in people with Hepatitis C, run by Gilead Sciences at 16 sites in Russia.

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 5 inclusion and 7 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Russia. 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 17 Apr 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 NCT01896193, 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 29 May 2015.