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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
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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
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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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Canada
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Ontario
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Canada
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Quebec
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Germany
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Munich
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Norway
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Lorenskog
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Zurich
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United Kingdom
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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
Government body
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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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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/study/NCT01364090
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Trial related presentations / publications
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.
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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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Contact person for public queries
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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
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