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

November 1, 2019 updated by: Kirby Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2300
        • Hunter Pharmacotherapy
      • Penrith, New South Wales, Australia, 2751
        • Nepean Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Belgium
      • Antwerp, Belgium
        • ZNA Stuivenberg / MSOC Free Clinic
      • Genk, Belgium
        • Ziekenhuis Oost Limburg / MSOC Limburg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2C7
        • Vancouver ID Research and Care Centre Society
    • Ontario
      • Toronto, Ontario, Canada, M4M 3P3
        • East Toronto Hepatitis C Program
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P1
        • CHUM - Centre Hospitalier de l'Universite de Montreal
  • Germany
      • Munich, Germany, 80331
        • Praxiszentrum Im Tal (PIT)
  • Norway
    • Lorenskog
      • Oslo, Lorenskog, Norway, 1478
        • Oslo/Akershus University hospitals
  • Switzerland
      • Basel, Switzerland, 4057
        • Basel Zentrum fur Suchtmedizin
      • Bern, Switzerland, 3010
        • Koda Bern/Poliklinik fur Infektiologe
      • Zurich, Switzerland, CH-8005
        • ARUD, Poliklinik Zokl 1
  • United Kingdom
      • London, United Kingdom, E1 4DG
        • East London Foundation NHS Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
Other Names:
  • PegInteron
Drug: Ribavirin
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
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).
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.
Other Names:
  • PegInteron
Drug: Ribavirin
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Efficacy
Time Frame: 36 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Adherence
Time Frame: 48 weeks
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
Treatment Response (ETR & SVR24)
Time Frame: 48 weeks
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
Behavioral and Quality of Life
Time Frame: 48 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Olav Dalgard, MD PhD, University Hospital, Akershus
  • Study Chair: Gregory Dore, MBBS, PhD, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP1007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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