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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pegylated interferon alfa 2b
Ribavirin
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C, treatment, injection drug users or receiving opiate substitution therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Pharmacotherapy
  • Nepean Hospital
  • St Vincent's Hospital
  • Royal Adelaide Hospital
  • Alfred Hospital
  • ZNA Stuivenberg / MSOC Free Clinic
  • Ziekenhuis Oost Limburg / MSOC Limburg
  • Vancouver ID Research and Care Centre Society
  • East Toronto Hepatitis C Program
  • CHUM - Centre Hospitalier de l'Universite de Montreal
  • Praxiszentrum Im Tal (PIT)
  • Oslo/Akershus University hospitals
  • Basel Zentrum fur Suchtmedizin
  • Koda Bern/Poliklinik fur Infektiologe
  • ARUD, Poliklinik Zokl 1
  • East London Foundation NHS Trust
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Treatment Duration (24 weeks)

Shortened Treatment Duration (12 Weeks)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 31, 2011
Last Updated
November 1, 2019
Sponsor
Kirby Institute
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01364090
Brief Title
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
hepatitis C, treatment, injection drug users or receiving opiate substitution therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment Duration (24 weeks)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Shortened Treatment Duration (12 Weeks)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa 2b
Other Intervention Name(s)
PegInteron
Intervention Description
Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
Primary Outcome Measure Information:
Title
Treatment Efficacy
Description
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.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Treatment Adherence
Description
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.
Time Frame
48 weeks
Title
Treatment Response (ETR & SVR24)
Description
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.
Time Frame
48 weeks
Title
Behavioral and Quality of Life
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Dore, MBBS, PhD
Organizational Affiliation
University of New South Wales
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olav Dalgard, MD PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Study Chair
Facility Information:
Facility Name
Hunter Pharmacotherapy
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
St Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
ZNA Stuivenberg / MSOC Free Clinic
City
Antwerp
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg / MSOC Limburg
City
Genk
Country
Belgium
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
Facility Name
East Toronto Hepatitis C Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4M 3P3
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Praxiszentrum Im Tal (PIT)
City
Munich
ZIP/Postal Code
80331
Country
Germany
Facility Name
Oslo/Akershus University hospitals
City
Oslo
State/Province
Lorenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Basel Zentrum fur Suchtmedizin
City
Basel
ZIP/Postal Code
4057
Country
Switzerland
Facility Name
Koda Bern/Poliklinik fur Infektiologe
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
ARUD, Poliklinik Zokl 1
City
Zurich
ZIP/Postal Code
CH-8005
Country
Switzerland
Facility Name
East London Foundation NHS Trust
City
London
ZIP/Postal Code
E1 4DG
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28610605
Citation
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.
Results Reference
derived

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

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