NCT01364090

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2011-06-02
• Last updated: 2019-11-18
• Results posted: 2017-10-18

Locations

17 sites across 7 countries: Australia, Belgium, Canada, Germany, Norway, Switzerland, United Kingdom