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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 - 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.
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
Treatment Adherence - 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.
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Treatment Response (ETR & SVR24) - 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.
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Behavioral and Quality of Life - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01364090
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

Summary results
Other publications