- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726517
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
October 19, 2018 updated by: Gilead Sciences
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
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
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-
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:
- Age ≥ 18 years, with chronic genotype 1 HCV infection
- HCV RNA equal to or greater than 10,000 IU/mL at screening
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.
|
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
|
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Experimental: LDV/SOF 12 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.
|
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.
|
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
|
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
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, 25 IU/mL) 12 weeks after stopping study treatment.
|
Posttreatment Week 12
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Baseline to Week 12
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The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
|
Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
Time Frame: Posttreatment Weeks 2, 4, 8, and 24
|
SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
|
Posttreatment Weeks 2, 4, 8, and 24
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Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Time Frame: Baseline to Posttreatment Week 24
|
|
Baseline 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.
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
October 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
November 10, 2012
First Submitted That Met QC Criteria
November 10, 2012
First Posted (Estimate)
November 15, 2012
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis, Chronic
- Hepatitis
- Hepatitis C
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Ledipasvir, sofosbuvir drug combination
Other Study ID Numbers
- GS-US-337-0118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Qualified external researchers may request IPD for this study after study completion.
For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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.
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