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)

NCT02368522 | Completed

• 1 other identifier: AI444-259
• Study Type: observational
• Target: 920
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis

Outcome Measures

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)

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

  Upto week 12 after the end of HCV treatment (SVR12)

Secondary Outcomes (6)

• 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)

• 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)

Study Arms (1)

Patients treated with and without exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from private practices and outpatients units in hospitals

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Hamburg, 20099, Germany

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 23, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-02

Locations

DE (1)