Hepatitis C VirusPhase 2NCT01713283

Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

A Phase 2 study testing SOF and RBV in people with Hepatitis C Virus, run by Gilead Sciences at 1 site in United States.

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 study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 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
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: 60 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Feb 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

First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
Treatment-experienced or treatment-naive
Chronic genotype 4 HCV infection
Not co-infected with HIV
Screening laboratory values within defined thresholds
Use of highly effective contraception methods
Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Who cannot join

History of any other clinically significant chronic liver disease
Pregnant or nursing female or male with pregnant female partner
History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Los Angeles, California

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Conditions: Hepatitis C Virus
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 GS-7977, PSI-7977, Sovaldi®
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVDrug
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)

Study groups in NCT01713283
Study group	Role	What they receive
SOF+RBV 12 Weeks	Experimental	Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 Weeks	Experimental	Treatment-naive and treatment-experienced participants will receive 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 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 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 Experiencing On-treatment Virologic Failure
On-treatment virologic failure was defined as:
1. Viral breakthrough: 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, or
2. Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir 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, or
3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Measured: Up to 24 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.

Oct 2012Feb 2014

First posted24 Oct 2012 (estimated)
Study startOct 2012
Primary completionNov 2013
Study completionFeb 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 C VirusStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01713283
Sponsor's protocol ID: GS-US-334-0114
Status last verified: Nov 2014
First submitted: 17 Oct 2012
Last updated: 25 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection
ClinicalTrials.gov ID: NCT01713283
Acronym / sponsor ID: GS-US-334-0114
Conditions: Hepatitis C Virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Nov 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 24 Oct 2012 (estimated)
Results: Posted 25 Nov 2014

Clinical summary

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

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SOF+RBV 12 Weeks	Experimental	Drug: SOF, Drug: RBVTreatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks.
SOF+RBV 24 Weeks	Experimental	Drug: SOF, Drug: RBVTreatment-naive and treatment-experienced participants will receive SOF+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 (7 listed)

First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
Treatment-experienced or treatment-naive
Chronic genotype 4 HCV infection
Not co-infected with HIV
Screening laboratory values within defined thresholds

Key exclusion criteria (4 listed)

History of any other clinically significant chronic liver disease
Pregnant or nursing female or male with pregnant female partner
History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

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: GS-7977, PSI-7977, Sovaldi®Sofosbuvir (SOF) 400 mg tablet administered orally once daily	Drug	SOF+RBV 12 Weeks, SOF+RBV 24 Weeks
RBVRibavirin (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)	Drug	SOF+RBV 12 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 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 Viral Relapse
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 25 Nov 2014, 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 12 Wk	31	20
SOF+RBV 24 Wk	29	26

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 12 Wk TN n = 14	SOF+RBV 12 Wk TE n = 17	SOF+RBV 24 Wk TN n = 14	SOF+RBV 24 Wk TE n = 15
Value	78.6	58.8	100.0	86.7

Population analysed: Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 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 12 Wk n = 31	SOF+RBV 24 Wk n = 29
Value	0	3.4

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 12 Wk	0 of 31 (0%)	28 of 31 (90.3%)	Not reported
SOF+RBV 24 Wk	3 of 29 (10.3%)	29 of 29 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Virus

RecruitingObservational study
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Not yet recruitingObservational study
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Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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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
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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF and RBV in people with Hepatitis C Virus, run by Gilead Sciences at 1 site in United States.

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 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 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 25 Nov 2014). 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 NCT01713283.

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 25 Nov 2014.