Phase 4
Completed N=93
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01364090 ↗
Enrolled (actual)
93
Serious AEs
11.8%
Results posted
Oct 2017
Primary outcomePrimary: Treatment Efficacy — 10; 51; 0 Participants
◆ Published Evidence
Emerging
16citations · ~2 / year
Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study.
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.
Linked Publications
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Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Efficacy |
10; 51; 0 | — |
| SECONDARY Treatment Adherence |
— | — |
| SECONDARY Treatment Response (ETR & SVR24) |
— | — |
| SECONDARY Behavioral and Quality of Life |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01364090) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.