SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients
NCT02473211 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2018-03-19
Summary
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.
Conditions
- Chronic Hepatitis C Infection
Interventions
- DRUG
-
Sofosbuvir
Sofosbuvir 400 mg tablet administered once daily
- DRUG
-
Daclatasvir
Daclatasvir 60mg tablet administered once daily
Sponsors & Collaborators
-
Beijing 302 Hospital
collaborator OTHER -
Humanity and Health Research Centre
lead OTHER
Principal Investigators
-
George KK Lau, MD · Humanity and Health GI and Liver Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-03-15
Countries
- China
Study Locations
More Related Trials
-
Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
NCT05601518 ·Status: UNKNOWN
-
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
NCT02074514 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
NCT02032901 ·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 SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis
NCT05467826 ·Status: UNKNOWN ·Phase: PHASE4
-
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
NCT01958281 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
NCT02472886 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
NCT02021656 ·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
-
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
NCT01965535 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
NCT02120300 ·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
-
Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
NCT02128542 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
NCT02551861 ·Status: WITHDRAWN ·Phase: PHASE2
-
Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
NCT02537379 ·Status: COMPLETED
-
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
-
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
NCT05092074 ·Status: UNKNOWN
-
Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
NCT01975675 ·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
-
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
-
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
NCT02556086 ·Status: WITHDRAWN ·Phase: PHASE2
-
Strategic Treatment Reduction in Very Early Liver Disease With 4 Weeks Sofosbuvir Plus Glecepravir-pibrentasvir
NCT03855917 ·Status: RECRUITING ·Phase: PHASE4
-
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
-
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
NCT01054729 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
NCT03061032 ·Status: UNKNOWN ·Phase: PHASE3