Clinical Trials Logo
  1. Home
  2. Chronic HCV Infection
  3. NCT01984294

Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection

Chronic HCV Infection Clinical Trial

Official title:
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

Clinical Trial Summary

This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01984294
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 2
Start date October 2013
Completion date July 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT01938430 - Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant Phase 2
Completed NCT01975675 - Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection Phase 3
Completed NCT02074514 - Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection Phase 3
Recruiting NCT05395416 - Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C Phase 2/Phase 3
Completed NCT03458481 - Phase 2 Study of Yimitasvir Phosphate Capsules Phase 2
Completed NCT02010255 - Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant Phase 2
Recruiting NCT00842205 - Role of Heme Oxygenase in the Pathogenesis of Hepatocellular Injury in Chronic Hepatitis C Virus (HCV) Infection N/A
Completed NCT02973503 - Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis Phase 3
Recruiting NCT03540212 - Clinical Pharmacokinetics of Daclatasvir/Sofosbuvir in Adolescents With Hepatitis C Virus Phase 2/Phase 3
Completed NCT02021656 - Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection Phase 3
Completed NCT02021643 - Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection Phase 3
Completed NCT02120300 - Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders Phase 2
Completed NCT03487107 - Phase 3 Study of Yimitasvir Phosphate Capsules Phase 3