- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01808248
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
September 5, 2014 updated by: Gilead Sciences
A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Expanded Access
Approved for sale to the public.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78215
- Alamo Medical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infection with genotype 2 or 3 HCV infection
- Cirrhosis determination
- Individual is treatment-experienced
- Screening laboratory values within defined thresholds
- Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
- Excessive alcohol ingestion or significant drug abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
|
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
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)
Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, < 15 IU/mL) at 12 weeks after stopping study treatment.
|
Posttreatment Week 12
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 12 weeks
|
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
|
Posttreatment Weeks 4 and 24
|
Percentage of Participants Experiencing On-treatment Virologic Failure
Time Frame: Up to 12 weeks
|
On-treatment virologic failure was defined as:
|
Up to 12 weeks
|
Percentage of Participants Experiencing Viral Relapse
Time Frame: Up to Posttreatment Week 24
|
Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
|
Up to Posttreatment Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rob Hyland, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 1, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 11, 2013
Study Record Updates
Last Update Posted (Estimate)
September 12, 2014
Last Update Submitted That Met QC Criteria
September 5, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
- Additional relevant MeSH terms:
- Anti-Infective Agents
- HCV
- Digestive System Diseases
- Antiviral Agents
- Sustained Virologic Response
- Virus Diseases
- Hepatitis C
- Hepatitis
- Liver Diseases
- Combination Therapy
- Physiological Effects of Drugs
- Ribavirin
- Hepatitis C, Chronic
- Pharmacologic Actions
- Therapeutic Uses
- Antimetabolites
- Immunologic Factors
- Interferon-alpha
- Flaviviridae Infections
- RNA Virus Infections
- RBV
- Hepatitis A
- Molecular Mechanisms of Pharmacological Action
- PEG
- Direct Acting Antiviral
- GS-7977
- Treatment-Naïve
- Hepatitis, Chronic
- Hepatitis, Viral, Human
- Peginterferon alfa-2a
- HCV genotype 3 (GT-3)
- Enterovirus Infections
- Picornaviridae Infections
- HCV genotype 2 (GT-2)
- Peginterferon Alfa 2a
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-334-0151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
Clinical Trials on SOF
-
McMaster UniversityAgency for Healthcare Research and Quality (AHRQ); Grading of Recommendations...Completed
-
Sanjay Gandhi Postgraduate Institute of Medical...Ram Manohar Lohia Institute of Medical Sciences, LucknowTerminated
-
Humanity & Health Medical Group LimitedWithdrawnHCV InfectionHong Kong
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical UniversityRecruitingChronic Hepatitis C InfectionChina
-
Gilead SciencesTerminatedHepatitis C Virus InfectionFrance, Spain, United States, Australia, Canada, Germany, United Kingdom, Italy, New Zealand, Puerto Rico
-
Kirby InstituteCompleted
-
Humanity and Health Research CentreBeijing 302 HospitalCompletedChronic Hepatitis C InfectionChina
-
Humanity and Health Research CentreUniversity of Maryland; Emory University; Beijing 302 HospitalWithdrawn
-
Stanford UniversityGilead SciencesCompleted
-
Gilead SciencesCompletedHepatitis C Virus InfectionUnited States, Puerto Rico