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NCT02250001 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02250001
Other study ID # AI444-244
Secondary ID
Status Completed
Phase N/A
First received September 24, 2014
Last updated May 1, 2017
Start date September 30, 2014
Est. completion date January 20, 2017

Study information
Verified date May 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 2974
Est. completion date January 20, 2017
Est. primary completion date January 20, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Local Institution Chuo-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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