Clinical trial NCT01364090: A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
Official title: A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b (PEG-IFN-alfa 2b) and Self Administered Ribavirin (RBV) for Patients With Chronic HCV Genotype 2 or 3 and Injection Drug Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
treatment
injection drug users or receiving opiate substitution therapy
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-06-02
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

Detailed description: The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* chronic HCV infection
* HCV genotype 2/3 infection
* active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
* compensated liver disease
* negative pregnancy test (within 24 hours of first dose of study medication)
* effective contraception for the duration of the study
* written informed consent

Exclusion Criteria:

* previous interferon or ribavirin therapy
* investigation drug use in the 6 weeks prior to first dose of study medication
* infection with HCV genotypes other than 2/3
* HIV infection
* HBV infection
* ongoing severe psychiatric disease
* frequent drug use that is judged by the treating physician to compromise treatment safety
* standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin

Primary outcomes:
measure: Treatment Efficacy
timeFrame: 36 weeks
Secondary outcomes:
measure: Treatment Adherence
timeFrame: 48 weeks
measure: Treatment Response (ETR & SVR24)
timeFrame: 48 weeks
measure: Behavioral and Quality of Life
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Hunter Pharmacotherapy
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Antwerp
country: Belgium
facility: ZNA Stuivenberg / MSOC Free Clinic
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg / MSOC Limburg
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Toronto
country: Canada
facility: East Toronto Hepatitis C Program
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Munich
country: Germany
facility: Praxiszentrum Im Tal (PIT)
city: Oslo
country: Norway
facility: Oslo/Akershus University hospitals
state: Lorenskog
city: Basel
country: Switzerland
facility: Basel Zentrum fur Suchtmedizin
city: Bern
country: Switzerland
facility: Koda Bern/Poliklinik fur Infektiologe
city: Zurich
country: Switzerland
facility: ARUD, Poliklinik Zokl 1
city: London
country: United Kingdom
facility: East London Foundation NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of New South Wales
name: Gregory Dore, MBBS, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Akershus
name: Olav Dalgard, MD PhD
role: STUDY_CHAIR
References:
citation: Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group. Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3.