Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C
INTEGRATE
Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts
2 other identifiers
observational
50
6 countries
18
Brief Summary
The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 3, 2017
March 1, 2017
1.8 years
November 4, 2013
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Virologic Response at 12 weeks (SVR12)
HCV RNA \<25 IU/mL, at 12 weeks (SVR12) after the last dose of anti-HCV treatment (telaprevir, PegIFN alfa, RBV)
Week 12
Secondary Outcomes (7)
adherence to telaprevir until Week 12
week 12
adherence to PegIFN alfa and RBV
at end of treatment (week 24)
on-treatment virologic response undetectable
week 12 and end of treatment ()
on treatment virologic response
week 12 and end of treatment ()
health-related quality of life based on EQ-5D
on day 1 and routine visits closest to week 4, 12, 24 and end of treatment and end of follow-up (up to approximately 60 weeks)
- +2 more secondary outcomes
Eligibility Criteria
Men or women who have HCV infection genotype 1, a quantifiable serum HCV RNA, documentation of the degree of liver fibrosis assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan), physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV, have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers), have a history of injecting drugs, and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center will be eligible to enter this study.
You may qualify if:
- Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.
You may not qualify if:
- Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Genk, Belgium
Unknown Facility
Haine-Saint-Paul, Belgium
Unknown Facility
Lomme, France
Unknown Facility
Montpellier, France
Unknown Facility
Perpignan, France
Unknown Facility
Berlin, Germany
Unknown Facility
Biberach, Germany
Unknown Facility
Kassel, Germany
Unknown Facility
München, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Maastricht, Netherlands
Unknown Facility
Lausanne, Switzerland
Unknown Facility
Zurich, Switzerland
Unknown Facility
Dundee, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Related Publications (1)
Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggmann P, Kunkel J, Keim S, Jakel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster GR. Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study. Infect Dis Ther. 2017 Jun;6(2):265-275. doi: 10.1007/s40121-017-0158-x. Epub 2017 May 5.
PMID: 28477061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 8, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 3, 2017
Record last verified: 2017-03