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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Study Start: 2018-05-08
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

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

Read More

Exclusion Criteria

• Participants under the age of 18

Other protocol defined inclusion/exclusion criteria could apply

Read More

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