Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU)

Completed

• Conditions: Hepatitis

• Registration Number: NCT02368522
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-15
• Study First Posted: 2015-02-23
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

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

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Exclusion Criteria

• Participation in a clinical trial or an early access program for HCV therapies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12)	Upto week 12 after the end of HCV treatment (SVR12)	SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment

Secondary Outcome Measures

Name	Time	Method
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)	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	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	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	Baseline (single assessment)	Previous LTx (if present)
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	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)	Upto week 24 after the end of HCV treatment (SVR24)	Metavir score (liver function and histology)

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Hamburg, Germany