Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA
NCT03318887 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130
Last updated 2017-10-24
Summary
Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.
Conditions
- Hepatitis C
Interventions
- DRUG
-
Sofosbuvir/daclatasvir with or without ribavirin
Direct-acting antiviral treatment for hepatitis C virus infection
Sponsors & Collaborators
-
Hospices Civils de Lyon
lead OTHER
Principal Investigators
-
Fabien Zoulim, MD, PhD · Hospices Civils de Lyon
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-01
- Primary Completion
- 2014-09-30
- Completion
- 2015-06-30
Countries
- France
Study Locations
More Related Trials
-
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT02822794 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
NCT01701401 ·Status: COMPLETED ·Phase: PHASE3
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT01987453 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
NCT02600351 ·Status: TERMINATED ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
NCT02994056 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection
NCT02480387 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
NCT02596880 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
NCT01965535 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
NCT02319031 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
NCT02673489 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
NCT01682720 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
NCT02781558 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
NCT04112303 ·Status: COMPLETED ·Phase: PHASE3
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
NCT02738333 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Generic Sofosbuvir and Ribavirin for Treatment-naive Genotype 2 Chronic Hepatitis C
NCT03453346 ·Status: COMPLETED ·Phase: NA
-
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
NCT04387526 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
NCT03343444 ·Status: UNKNOWN ·Phase: PHASE3
-
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
NCT02472886 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
NCT02074514 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
NCT02722837 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
NCT01713283 ·Status: COMPLETED ·Phase: PHASE2
-
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
NCT03074331 ·Status: COMPLETED ·Phase: PHASE3
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
NCT01938430 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
NCT01975675 ·Status: COMPLETED ·Phase: PHASE3
-
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
NCT01542788 ·Status: COMPLETED ·Phase: PHASE3