Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor Bristol-Myers Squibb
Start date September 2014
End date November 2016
Trial size 3000 participants
Trial identifier NCT02250001, AI444-244

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Arm
Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.