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

NCT03208322 | Withdrawn

• 1 other identifier: AI447-121
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

DCV + ASV at a sentinel site

patients with chronic hepatitis C (CHC) who are being given at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) for the treatment and cure of CHC at the sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico.

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

DCV + ASV at a sentinel site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include all patients receiving at least 1 dose of DCV and ASV at the selected sites during the specified 24 month study period. Included patients will be: * At least 18 years of age with CHC, Genotype(GT)-1 * Treatment-naïve and treatment-experienced (null or partial) responders * Intolerant to interferon (IFN) * With or without cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Df, Mexico City, 10700, Mexico

Location

Local Institution

Magdalena de las Salinas, Mexico City, 07760, Mexico

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: November 30, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

ME (2)