Clinical trial NCT02368522: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from private practices and outpatients units in hospitals

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.


Eligibility criteria: 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

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)
timeFrame: 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)
timeFrame: Upto week 12 after the end of HCV treatment (SVR12)
measure: Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials
timeFrame: Upto week 12 after the end of HCV treatment (SVR12)
measure: Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation
timeFrame: Until completion of study
measure: 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
timeFrame: Baseline (single assessment)
measure: 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
timeFrame: Baseline (single assessment)
measure: 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)
timeFrame: Upto week 24 after the end of HCV treatment (SVR24)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: