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

NCT01364090 | Completed Phase 4 Results DMC

• 1 other identifier: VHCRP1007
• Study Type: interventional
• Target: 93
• Locations: 7 countries
• Sites: 17

Brief 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.

Conditions

Hepatitis C, Chronic

Keywords

hepatitis C; treatment; injection drug users or receiving opiate substitution therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatment Adherence

  48 weeks

• Treatment Response (ETR & SVR24)

  48 weeks

• Behavioral and Quality of Life

  48 weeks

Study Arms (2)

Standard Treatment Duration (24 weeks)

ACTIVE COMPARATOR

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; Drug: Ribavirin

Shortened Treatment Duration (12 Weeks)

EXPERIMENTAL

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; Drug: Ribavirin

Interventions

Pegylated interferon alfa 2b DRUG

Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.

Also known as: PegInteron

Shortened Treatment Duration (12 Weeks); Standard Treatment Duration (24 weeks)

Ribavirin DRUG

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

Shortened Treatment Duration (12 Weeks); Standard Treatment Duration (24 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirby Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (17)

Hunter Pharmacotherapy

Newcastle, New South Wales, 2300, Australia

Location

Nepean Hospital

Penrith, New South Wales, 2751, Australia

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

ZNA Stuivenberg / MSOC Free Clinic

Antwerp, Belgium

Location

Ziekenhuis Oost Limburg / MSOC Limburg

Genk, Belgium

Location

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z2C7, Canada

Location

East Toronto Hepatitis C Program

Toronto, Ontario, M4M 3P3, Canada

Location

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 1P1, Canada

Location

Praxiszentrum Im Tal (PIT)

Munich, 80331, Germany

Location

Oslo/Akershus University hospitals

Oslo, Lorenskog, 1478, Norway

Location

Basel Zentrum fur Suchtmedizin

Basel, 4057, Switzerland

Location

Koda Bern/Poliklinik fur Infektiologe

Bern, 3010, Switzerland

Location

ARUD, Poliklinik Zokl 1

Zurich, CH-8005, Switzerland

Location

East London Foundation NHS Trust

London, E1 4DG, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• Cunningham EB, Hajarizadeh B, Dalgard O, Amin J, Hellard M, Foster GR, Bruggmann P, Conway B, Backmund M, Robaeys G, Swan T, Marks PS, Quiene S, Applegate TL, Weltman M, Shaw D, Dunlop A, Bruneau J, Midgard H, Bourgeois S, Thurnheer MC, Dore GJ, Grebely J; ACTIVATE Study Group. Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. BMC Infect Dis. 2017 Jun 13;17(1):420. doi: 10.1186/s12879-017-2517-3.

  PMID: 28610605 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Jason Grebely
• Organization: Viral Hepatits Clinical Research Program - The Kirby Institute - UNSW Sydney

Jgrebely@kirby.unsw.edu.au

+61 2938 50957

Study Officials

• Gregory Dore, MBBS, PhD

  University of New South Wales

  STUDY CHAIR

• Olav Dalgard, MD PhD

  University Hospital, Akershus

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 18, 2019
• Results First Posted: October 18, 2017

Record last verified: 2019-11

Locations

AU (5); GB (2); CA (3); DE (1); NO (1); BE (2); CH (3)