Overview

This trial is active, not recruiting.

Condition hepatitis
Sponsor Bristol-Myers Squibb
Start date December 2014
End date December 2016
Trial size 1000 participants
Trial identifier NCT02368522, AI444-259

Summary

The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm

Primary Outcomes

Measure
Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12)
time frame: Upto week 12 after the end of HCV treatment (SVR12)

Secondary Outcomes

Measure
SVR12 in patients treated with DCV-containing regimens in real-life by treatment regimen, genotype, cirrhosis stage, HCV-treatment experience, HIV coinfection, and previous LTx (if present)
time frame: Upto week 12 after the end of HCV treatment (SVR12)
Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials
time frame: Upto week 12 after the end of HCV treatment (SVR12)
Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation
time frame: Until completion of study
Demographic and clinical characteristics and treatment patterns of patients starting a new HCV treatment regimen (with or without DCV), overall and by treatment regimen,GT,cirrhosis stage,HCV-treatment experience,HIV co-infection,and previous LTx
time frame: Baseline (single assessment)
Comparison of demographic and clinical characteristics of patients starting a new HCV treatment regimen (with or without DCV) by treatment regimen and to identify factors associated with the initiation of different regimens
time frame: Baseline (single assessment)
SVR 24 in patients treated with DCV-containing regimens in real-life clinical care, change of Child-Pugh Score and Metavir score as well as change of patient related outcomes (EQ-5D and SF-36 questionnaires measuring quality of life)
time frame: Upto week 24 after the end of HCV treatment (SVR24)

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Adult (≥18 years at inclusion) - Diagnosed with a chronic hepatitis C infection - Whose physician has already decided to initiate a new HCV treatment or a new daclatasvir-containing regimen - Informed consent to participate in the study Exclusion Criteria: - Participation in a clinical trial or an early access program for HCV therapies

Additional Information

Official title Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.