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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01364090




Registration number
NCT01364090
Ethics application status
Date submitted
31/05/2011
Date registered
2/06/2011
Date last updated
18/11/2019

Titles & IDs
Public title
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
Scientific 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
Secondary ID [1] 0 0
VHCRP1007
Universal Trial Number (UTN)
Trial acronym
ACTIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pegylated interferon alfa 2b
Treatment: Drugs - Ribavirin

Active comparator: Standard Treatment Duration (24 weeks) - Subjects with detectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 24 and follow-up for an additional 24 weeks following treatment completion (48 weeks in total).

Experimental: Shortened Treatment Duration (12 Weeks) - Subjects with undetectable HCV RNA after four weeks of therapy will continue on PEG-IFN and ribavirin until week 12 and follow-up for an additional 24 weeks following treatment completion (36 weeks in total).


Treatment: Drugs: Pegylated interferon alfa 2b
Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Treatment: Drugs: Ribavirin
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Efficacy
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
Treatment Adherence
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Treatment Response (ETR & SVR24)
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Behavioral and Quality of Life
Timepoint [3] 0 0
48 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Hunter Pharmacotherapy - Newcastle
Recruitment hospital [2] 0 0
Nepean Hospital - Penrith
Recruitment hospital [3] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment postcode(s) [2] 0 0
2751 - Penrith
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Germany
State/province [6] 0 0
Munich
Country [7] 0 0
Norway
State/province [7] 0 0
Lorenskog
Country [8] 0 0
Switzerland
State/province [8] 0 0
Basel
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern
Country [10] 0 0
Switzerland
State/province [10] 0 0
Zurich
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Dore, MBBS, PhD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01364090