Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT02250001
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Detailed Description

Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated

Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Study Timeline

• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Study Start: 2014-09-30
• Primary Completion: 2017-01-20
• Study Completion: 2017-01-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2974

Inclusion Criteria

• Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)	28 weeks

Secondary Outcome Measures

Name	Time	Method
Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)	48 weeks

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-ku, Tokyo, Japan