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Completed

NCT Number: 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)

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.

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Key information

Conditions

Hepatitis Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Hamburg, 20099, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

    SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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)

    Previous LTx (if present)

  5. 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)

  6. 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)

    Metavir score (liver function and histology)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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