Overview

Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.
Phase:
Phase 4
Details
Lead Sponsor:
Getz Pharma
Collaborator:
Dimension Research
Treatments:
Interferon-alpha
Peginterferon alfa-2a
Ribavirin