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

Bristol-Myers Squibb2,974 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,974

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Locations (1)

Local Institution

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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)

Time frame: 28 weeks

Secondary Outcomes

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)

Time frame: 48 weeks

Data from ClinicalTrials.gov

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