Hepatitis C Virus Infection Clinical Trial
Official title:
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Verified date | March 2017 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
Status | Completed |
Enrollment | 153 |
Est. completion date | June 30, 2016 |
Est. primary completion date | March 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Key Inclusion Criteria: - Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study - Chronic genotype 1 HCV infection - HCV treatment-naive - HCV RNA > 10,000 IU/mL at screening - Absence of cirrhosis - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male Key Exclusion Criteria: - Pregnant or nursing female or male with pregnant female partner - Infection with hepatitis B virus (HBV) - Current or prior history of clinical hepatic decompensation - Chronic use of systemic immunosuppressive agents - History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol - For HIV-1/HCV co-infected individuals: - Opportunistic infection within 6 months prior to screening - Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline - Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
Estonia, Russian Federation,
Zhdanov K., Morozov V., Orlova-Morozova E.A., Salupere R., Kozhevnikova G., et al. Preliminary Results of an Evaluation of Ledipasvir/Sofosbuvir in Treatment-Naive Patients with Chronic HCV or HCV/HIV Co-Infection and Retreatment of Sofosbuvir-treated Pat
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Posttreatment Week 12 | |
Primary | Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) | Up to 12 weeks | ||
Secondary | Percentage of Participants With Sustained Virologic Response (SVR) 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. | Posttreatment Weeks 4 and 24 | |
Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Up to 12 weeks | ||
Secondary | HCV RNA Change From Day 1 | Up to 12 weeks | ||
Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as On-treatment virologic failure confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough), confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently = LLOQ through 8 weeks of treatment (ie, nonresponse) Relapse HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement |
Up to Posttreatment Week 24 | |
Secondary | Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 | Up to Posttreatment Week 4 | ||
Secondary | For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4 | Up to Posttreatment Week 4 |
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