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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Kirby Institute
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01364090
First received: May 31, 2011
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Pegylated interferon alfa 2b
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 Injection Drug Use

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • Treatment Efficacy [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure is the proportion 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.


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Evaluate the safety and tolerability of 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.

  • Treatment Adherence [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Treatment response (ETR & SVR24) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Behavioral and Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PegInteron
Drug: Ribavirin
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364090

Contacts
Contact: Sophie Quiene +61 2 9385 9970 squiene@kirby.unsw.edu.au
Contact: Pip Marks, BSc, MPH +61 2 9385 0886 pmarks@kirby.unsw.edu.au

Locations
Australia, New South Wales
Hunter Pharmacotherapy Recruiting
Newcastle, New South Wales, Australia, 2300
Contact: Rohan Holland    +61 2 4016 4514    rohan.holland@hnehealth.nsw.gov.au   
Principal Investigator: Adrian Dunlop, MBBS         
Nepean Hospital Not yet recruiting
Penrith, New South Wales, Australia, 2751
Contact: Sue Sellar    +612 47343466    Sue.Sellar@swahs.health.nsw.gov.au   
Principal Investigator: Martin Weltman         
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Ali Sevehon    +61 2 8382 3825    asevehon@stvincents.com.au   
Principal Investigator: Gregory Dore, MBS PhD         
Sub-Investigator: Gail Matthews, MBBS PhD         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Catherine Ferguson    +61 8 8222 2494    Catherine.Ferguson@health.sa.gov.au   
Principal Investigator: David Shaw         
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sally von Bibra    +61 03 9282 2261    svonbibra@burnet.edu.au   
Principal Investigator: Margaret Hellard         
Belgium
ZNA Stuivenberg / MSOC Free Clinic Recruiting
Antwerp, Belgium
Contact: Kristof Leusneuck    +32 (0)3217 25 85    Kristof.Lesneuck@sgs.com   
Principal Investigator: Stefan Bourgeois         
Sub-Investigator: Catharina Mathei         
Ziekenhuis Oost Limburg / MSOC Limburg Recruiting
Genk, Belgium
Contact: Anita Eevers       endoscopie@zol.be   
Principal Investigator: Geert Robaeys         
Sub-Investigator: Rita Verrando         
Canada, British Columbia
Vancouver ID Research and Care Centre Society Recruiting
Vancouver, British Columbia, Canada, V6Z2C7
Contact: Shawn Sharma    +1 604-642-6429    shawn.sharma@vidc.ca   
Principal Investigator: Brian Conway         
Canada, Ontario
East Toronto Hepatitis C Program Recruiting
Toronto, Ontario, Canada, M4M 3P3
Contact: Kate Mason    +1 416 4613577 ext 387    kmason@srchc.com   
Principal Investigator: Jeff Powis         
Canada, Quebec
CHUM - Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 1P1
Contact: Marie-Claire Chayer    +1 514 890 8321    marie-claire.chayer.chum@ssss.gouv.qc.ca   
Principal Investigator: Julie Bruneau         
Finland
Espoo Treatment and Rehabilitation A-clinic Withdrawn
Espoo, Finland, 02600
Germany
Praxiszentrum Im Tal (PIT) Recruiting
Munich, Germany, 80331
Contact: Nicole Widder       Birgit.Ruehl@p-i-t.info   
Principal Investigator: Markus Backmund         
CONCEPT Center for Addiction Treatment Withdrawn
Munich, Germany
Norway
Oslo/Akershus University hospitals Recruiting
Oslo, Lorenskog, Norway, 1478
Contact: Jessica Andreassen    +47 02900    Jessica.Andreassen@ahus.no   
Principal Investigator: Olav Dalgard         
Sub-Investigator: Peter Krajci         
Switzerland
Basel Zentrum fur Suchtmedizin Recruiting
Basel, Switzerland, 4057
Contact: Christine Huber       C.Huber@suchtmedizin.ch   
Principal Investigator: Claude Scheidegger         
Koda Bern/Poliklinik fur Infektiologe Recruiting
Bern, Switzerland, 3010
Contact: Cornelia Krismer    +41 (0)31 632 88 44    Cornelia.Krismer@insel.ch   
Principal Investigator: Christine Thurnheer         
ARUD, Poliklinik Zokl 1 Recruiting
Zurich, Switzerland, CH-8005
Contact: Tina Horschik       tina73@gmx.ch   
Principal Investigator: Philip Bruggmann         
United Kingdom
East London Foundation NHS Trust Recruiting
London, United Kingdom, E1 4DG
Contact: David Axten    +44 (0)20 8121 5348    David.Axten@eastlondon.nhs.uk   
Principal Investigator: Graham Foster         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Maxine Gorman       Maxine.Gorman@nottshc.nhs.uk   
Principal Investigator: Stephen Ryder         
Sponsors and Collaborators
Kirby Institute
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Gregory Dore, MBBS, PhD University of New South Wales
Study Chair: Olav Dalgard, MD PhD University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01364090     History of Changes
Other Study ID Numbers: VHCRP1007
Study First Received: May 31, 2011
Last Updated: January 13, 2014
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ethics Review Committee
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Norway: Regional Ethics Commitee
Switzerland: Ethikkommission
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Kirby Institute:
hepatitis C
treatment
injection drug users or receiving opiate substitution therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014