Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
NCT02727933 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1941
Last updated 2022-01-21
Summary
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.
Conditions
- Hepatitis C
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-03
- Primary Completion
- 2020-07-05
- Completion
- 2020-07-05
Countries
- South Korea
Study Locations
More Related Trials
-
Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients
NCT02282709 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
NCT02907996 ·Status: COMPLETED
-
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
NCT03740230 ·Status: COMPLETED
-
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
NCT02021656 ·Status: COMPLETED ·Phase: PHASE3
-
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
NCT02250001 ·Status: COMPLETED
-
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
-
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
NCT02262728 ·Status: COMPLETED ·Phase: PHASE2
-
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 Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
NCT01797848 ·Status: WITHDRAWN ·Phase: PHASE3
-
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
NCT02175966 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
NCT02021643 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
NCT02124044 ·Status: COMPLETED ·Phase: PHASE2
-
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
NCT02738333 ·Status: COMPLETED ·Phase: PHASE3
-
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
NCT02323594 ·Status: COMPLETED ·Phase: PHASE1
-
Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism
NCT02292966 ·Status: WITHDRAWN ·Phase: PHASE4
-
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
NCT01628692 ·Status: COMPLETED ·Phase: PHASE2
-
Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
NCT01492504 ·Status: COMPLETED
-
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
-
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
-
Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks
NCT03122132 ·Status: COMPLETED
-
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
NCT01754974 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Study in HCV Chronic Infection
NCT01945008 ·Status: COMPLETED
-
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
NCT02825212 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
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
-
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
NCT02349048 ·Status: COMPLETED ·Phase: PHASE2