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

Hepatitis C, Chronic Clinical Trial

— ACTIVATE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364090
• Other study ID #: VHCRP1007
• Status: Completed
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2019
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• 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.
• Ribavirin
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Hunter Pharmacotherapy	Newcastle	New South Wales
Australia	Nepean Hospital	Penrith	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Belgium	ZNA Stuivenberg / MSOC Free Clinic	Antwerp
Belgium	Ziekenhuis Oost Limburg / MSOC Limburg	Genk
Canada	CHUM - Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	East Toronto Hepatitis C Program	Toronto	Ontario
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
Germany	Praxiszentrum Im Tal (PIT)	Munich
Norway	Oslo/Akershus University hospitals	Oslo	Lorenskog
Switzerland	Basel Zentrum fur Suchtmedizin	Basel
Switzerland	Koda Bern/Poliklinik fur Infektiologe	Bern
Switzerland	ARUD, Poliklinik Zokl 1	Zurich
United Kingdom	East London Foundation NHS Trust	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 weeks
Secondary	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.	48 weeks
Secondary	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.	48 weeks
Secondary	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.	48 weeks