Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)
Terminated
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT03500562
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- Participants 18 years of age and older
- Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label
Exclusion Criteria
- Participants under the age of 18
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of adverse events (AEs) Approximately 72 weeks Number of serious adverse events (SAEs) Approximately 72 weeks
- Secondary Outcome Measures
Name Time Method Number of participants who discontinue therapy due to an AE Approximately 72 weeks Effectiveness of daclatasvir DCV-based therapy Approximately 72 weeks As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)
Trial Locations
- Locations (1)
Local Institution
🇨🇳Guangzhou, Guangdong, China
Local Institution🇨🇳Guangzhou, Guangdong, China