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)

Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368522
• Other study ID #: AI444-259
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: March 3, 2017
• Start date: December 2014
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Germany	Local Institution	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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	Previous LTx (if present)	Baseline (single assessment)
Secondary	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)
Secondary	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)	Metavir score (liver function and histology)	Upto week 24 after the end of HCV treatment (SVR24)

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form