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Trial record 1 of 1 for:    Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-Containing Regimens in Real –Life Clinical Care in Europe
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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)

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ClinicalTrials.gov Identifier: NCT02368522
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis

Study Type : Observational
Actual Enrollment : 920 participants
Observational Model: Cohort
Time Perspective: Other
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 Start Date : December 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients treated with and without exposure



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from private practices and outpatients units in hospitals
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368522


Locations
Germany
Local Institution
Hamburg, Germany, 20099
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02368522     History of Changes
Other Study ID Numbers: AI444-259
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents