A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT01364090
• Date of registration: 31/05/2011
• Primary sponsor: Kirby Institute
• Public title: A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3 ACTIVATE
• Scientific title: A Phase IV, Open-label, Multicentre, International Trial of Response Guided Treatment With Directly Observed Pegylated Interferon Alfa 2b and Self Administered Ribavirin for Patients With Chronic HCV Genotype 2 or 3 and Ongoing Injection Drug Use
• Date of first enrolment: June 2012
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01364090
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Canada, Finland, Germany, Norway, Switzerland, United Kingdom

Contacts

• Name: Marianne Byrne, BSc, MPM

• Name: Olav Dalgard, MD PhD
• Affiliation: University Hospital, Akershus

• Name: Gregory Dore, MBBS, PhD
• Affiliation: University of New South Wales

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age

- chronic HCV infection

- HCV genotype 2/3 infection

- active injection drug use (within 12 weeks prior to consent)

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: Pegylated interferon alfa 2b

Drug: Ribavirin

Primary Outcome(s)

Treatment Efficacy [Time Frame: 48 weeks]

Secondary Outcome(s)

Behavioural and Quality of Life [Time Frame: 48 weeks]

Safety and Tolerability [Time Frame: 48 weeks]

Treatment Adherence [Time Frame: 48 weeks]

Treatment response (ETR & SVR12) [Time Frame: 36 weeks]

Secondary ID(s)

VHCRP1007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck