Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens

Completed

• Conditions: Hepatitis C
• Interventions: Other: Non-interventional

• Registration Number: NCT03366610
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Males or females 18 years of age or older at initiation of prior DCV-based therapy
• Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks
• Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Previously Treated with Daclatasvir-Based Regimens	Non-interventional	Patients in China Previously Treated with Daclatasvir-Based Regimens

Primary Outcome Measures

Name	Time	Method
Incidence of hepatic disease progression events	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Durability of virologic response	up to 5 years	assessed by response in subjects previously treated with DCV-based therapy who achieved sustained virologic response at 12 or 24 weeks(SVR12/24) after the end of treatment
Change in liver stiffness	baseline up to 5 years	measured using elastography values
Number of subjects with HCV sequence variants	baseline up to 5 years	presence of HCV sequence variants over time in subjects who failed to prior Daclatasvir(DCV)-based therapy
Distribution of HCV retreatment patterns	baseline up to 5 years	distribution of HCV retreatment patterns including number of subjects receiving retreatment, retreatment regimen, retreatment duration and retreatment results

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Beijing, Beijing, China