Hepatitis C VirusPhase 3NCT01838590

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

A Phase 3 study testing SOF and RBV in people with Hepatitis C Virus, run by Gilead Sciences at 2 sites in Egypt.

Completed

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

Trial summary

This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with 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: 103 participants
Where: 2 sitesEgypt
Study dates: Mar 2013to Aug 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

Treatment experienced and naïve subjects
Chronic genotype 4 HCV-infection
Not co-infected with HIV
Screening laboratory values within defined thresholds
Use of highly effective contraception methods
Subject 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 subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

Study site
Al Mansurah
Study site
Cairo

Other trials in Egypt

About this study

Official title: A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.

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

Conditions: Hepatitis C Virus
Being tested: SOF, RBV
Keywords: Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action, HCV genotype 4 (GT-4), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977
Medical subject headings: Hepatitis C, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections

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
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVDrug
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT01838590
Study group	Role	What they receive
SOF+RBV 12 Weeks	Experimental	Participants will receive SOF+RBV for 12 weeks. Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 Weeks	Experimental	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
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
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 24

Timeline

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

Mar 2013Aug 2014

First posted24 Apr 2013 (estimated)
Study startMar 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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01838590
Sponsor's protocol ID: GS-US-334-0138
Status last verified: May 2015
First submitted: 15 Apr 2013
Last updated: 22 May 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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

All Hepatitis C Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.
ClinicalTrials.gov ID: NCT01838590
Acronym / sponsor ID: GS-US-334-0138
Conditions: Hepatitis C Virus
Keywords: Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: May 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 22 May 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 is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with 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: RBVParticipants will receive SOF+RBV for 12 weeks.
SOF+RBV 24 Weeks	Experimental	Drug: SOF, Drug: RBVParticipants 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 (6 listed)

Treatment experienced and naïve subjects
Chronic genotype 4 HCV-infection
Not co-infected with HIV
Screening laboratory values within defined thresholds
Use of highly effective contraception methods

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 subject 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: Sovaldi®, GS-7977Sofosbuvir (SOF) 400 mg tablet administered orally once daily	Drug	SOF+RBV 12 Weeks, SOF+RBV 24 Weeks
RBVRibavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 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.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks

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 24

Results and safety

Results posted to the registry on 22 May 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 12 Weeks	52	40
SOF+RBV 24 Weeks	51	46

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 Weeks, TN n = 25	SOF+RBV 12 Weeks, TE n = 27	SOF+RBV 24 Weeks, TN n = 24	SOF+RBV 24 Weeks, TE n = 27
Value	84.0	70.4	91.7	88.9

Population analysed: Full Analysis Set: participants with genotype 4 HCV infection who were randomized and received at least one dose of study drug

Primary outcome: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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

Measure	SOF+RBV 12 Weeks n = 52	SOF+RBV 24 Weeks n = 51
Value	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 12 Weeks	0 of 52 (0%)	34 of 52 (65.4%)	Not reported
SOF+RBV 24 Weeks	2 of 51 (3.9%)	38 of 51 (74.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Virus

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)

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 study director

Gilead Sciences

2 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 Virus, run by Gilead Sciences at 2 sites in Egypt.

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 6 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 22 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 2 sites in Egypt. 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 22 May 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 NCT01838590.

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 22 May 2015.