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

NCT02601976 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-09-27

Study results available
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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.

Conditions

  • Hepatitis C

Interventions

DRUG

Peginterferon alfa-2a

PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.

DRUG

Ribavirin

Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors & Collaborators

  • Dimension Research

    collaborator INDUSTRY

  • Getz Pharma

    lead INDUSTRY

Principal Investigators

  • Dr. Khawar Mehdi, MD · Getz Pharma Pakistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-09-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601976 on ClinicalTrials.gov