Last reviewed · How we verify
Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection (EUROP)
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.
Details
| Lead sponsor | Getz Pharma |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 64 |
| Start date | 2010-08 |
| Completion | 2014-09 |
Conditions
- Hepatitis C
Interventions
- Peginterferon alfa-2a
- Ribavirin
Primary outcomes
- Number of Participants With Sustained Virological Response (SVR) — Post treatment Week 24
To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR - Number of Participants With End Treatment Response — Upto 48 weeks
To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin