MedTrace Logo

Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C

NCT01649245 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2013-01-15

No results posted yet for this study

Summary

It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks.

hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Reiferon retard

Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is \>75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses.

Sponsors & Collaborators

  • MinaPharm Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Imam Waked, MD · National Liver Institute, Egypt

  • Gamal Esmat, MD · Faculty of Medicine - Cairo University - Egypt

  • Hassan Hamdy, MD · Faculty of Medicine - Ain Shams University - Egypt

  • Mohamed kohla, MD · National Liver Institute, Egypt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Egypt

More Related Trials

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 NCT01649245 on ClinicalTrials.gov