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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Chuo-ku, Tokyo, 104-0033, Japan

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Sep 26, 2014
Registry last updated: May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed