A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3 - Full Text View

Purpose

This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users 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 Ongoing Injection Drug Use

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Interferon Alfa-2b Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:

Treatment Efficacy [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
The primary oucome measure is the proportion of patients with undetectable HCV RNA at 24 weeks post enf of treatment (SVR24) following directly oberved PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants withe undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with detectable HCV RNA 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 oberved PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with detectable HCV RNA 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 oberved PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with detectable HCV RNA at week 4 of therapy.
Treatment response (ETR & SVR12) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Evaluate the percentage with undecetable HCV RNA at end of treatment (ETR) and 12 weeks post end of treatment (SVR12) in particpants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with detectable HCV RNA at week 4 of therapy.
Behavioural 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 undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with detectable HCV RNA at week 4 of therapy.

Estimated Enrollment:	100
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (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. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have undetectable HCV RNA at week 4 and 24 weeks in those that have detectable HCV RNA 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 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

Contacts and Locations

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

Contacts

Contact: Marianne Byrne, BSc, MPM	+61 2 9385 9209	mbyrne@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: Emma Pollard +612 47343484 Emma.Pollard@swahs.health.nsw.gov.au
Principal Investigator: Martin Weltman
St Vincent's Hospital	Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Debbie Wilson +61 2 8382 3602 dwilson1@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	Not yet 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: Lesley Gallagher +1 604 642-6429 lgalla@mail.ubc.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	Not yet recruiting
Espoo, Finland, 02600
Contact: Sari Rissanen +358 45 6577464 sari.rissanen@a-klinikka.fi
Principal Investigator: Kaarlo Simojoki
Germany
Praxiszentrum Im Tal (PIT)	Not yet recruiting
Munich, Germany, 80331
Contact: Nicole Widder Birgit.Ruehl@p-i-t.info
Principal Investigator: Markus Backmund
CONCEPT Center for Addiction Treatment	Not yet recruiting
Munich, Germany
Contact: Stefan Walcher kontakt@moviemed.de
Principal Investigator: Stefan Walcher
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	Not yet 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

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 15, 2013
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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a

Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013

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