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Completed

NCT Number: NCT01364090

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hunter Pharmacotherapy, Newcastle, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PegInteron

Ribavirin

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: ACTIVATE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2011
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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