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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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VHCRP1007
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Universal Trial Number (UTN)
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Trial acronym
ACTIVATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment Efficacy
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Assessment method [1]
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The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (=15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
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Timepoint [1]
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36 weeks
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Secondary outcome [1]
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Treatment Adherence
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Assessment method [1]
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Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.
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Timepoint [1]
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48 weeks
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Secondary outcome [2]
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Treatment Response (ETR & SVR24)
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Assessment method [2]
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Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
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Timepoint [2]
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48 weeks
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Secondary outcome [3]
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Behavioral and Quality of Life
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Assessment method [3]
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Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.
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Timepoint [3]
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48 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2015
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Sample size
Target
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Accrual to date
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Final
93
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Hunter Pharmacotherapy - Newcastle
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Recruitment hospital [2]
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Nepean Hospital - Penrith
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Recruitment hospital [3]
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St Vincent's Hospital - Sydney
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Recruitment hospital [4]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2300 - Newcastle
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Recruitment postcode(s) [2]
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2751 - Penrith
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerp
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Belgium
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Genk
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Canada
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British Columbia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Canada
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Quebec
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Country [6]
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Germany
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Munich
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Country [7]
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Norway
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State/province [7]
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Lorenskog
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Country [8]
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Switzerland
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State/province [8]
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Basel
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Country [9]
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Switzerland
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State/province [9]
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Bern
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Country [10]
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Switzerland
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State/province [10]
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Zurich
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Country [11]
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United Kingdom
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State/province [11]
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London
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Country [12]
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United Kingdom
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State/province [12]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01364090
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gregory Dore, MBBS, PhD
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Address
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University of New South Wales
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01364090
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