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NCT03208322 Clinical Trial

Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Hepatitis C Clinical Trial

Official title:
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03208322
Other study ID # AI447-121
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 30, 2018
Est. completion date February 27, 2019

Study information
Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 27, 2019
Est. primary completion date February 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - at least 18 years of age with CHC, GT-1 - treatment-naïve and treatment-experienced (null or partial) responders - intolerant to interferon (IFN) - with or without cirrhosis Exclusion Criteria: - patients who received DCV and ASV as part of a clinical trial - patients who received DCV and ASV for any indication other than that which is locally approved - contraindications included in the approved Mexican prescribing information Other protocol defined inclusion/exclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Mexico Local Institution Df Distrito Federal
Mexico Local Institution Magdalena De Las Salinas Distrito Federal

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse events (AEs) reported by patients treated with at least one dose of daclatasvir (DCV) and at least one dose of asunaprevir (ASV) and reported to the Health Authority (HA) during a specified period. 24 months
Secondary The adverse events (AEs) reported to the Health Authority (HA) during a specified period in table format identifying the report number, patient Identification number, and type of adverse event (AE). 24 months
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