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NCT03500562 Clinical Trial

Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)

Chronic Hepatitis C Clinical Trial

Official title:
Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03500562
Other study ID # AI444-396
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 8, 2018
Est. completion date March 29, 2019

Study information
Verified date August 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date March 29, 2019
Est. primary completion date March 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Local Institution Beijing Beijing
China Local Institution Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) Approximately 72 weeks
Primary Number of serious adverse events (SAEs) Approximately 72 weeks
Secondary Number of participants who discontinue therapy due to an AE Approximately 72 weeks
Secondary Effectiveness of daclatasvir DCV-based therapy 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) Approximately 72 weeks
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