NCT01649245

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

Efficacy and Safety of a Hansenula-derived Pegylated Interferon α2a (Reiferon Retard®) in Treatment of Patients With Chronic Hepatitis C Virus Infection: A National Multi-center Phase IV Open Label Non-Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: MinaPharm Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multicenter , Phase IV, open labeled, non-randomized trial to assess the Efficacy of Hansenula-derived recombinant pegylated interferon α 2a (Reiferon Retard® in treatment of naïve chronic hepatitis c virus Egyptian patients. Each participant will be subject to thorough history taking, complete clinical examination, Biochemical laboratory and hematological tests, U/S imaging as well as histologic assessment of liver disease stage and severity to ensure his/her eligibility to be enrolled in the study according to predetermined inclusion and exclusion criteria . Eligible subjects will be treated with Reiferon Retard® 160 µg once weekly by subcutaneous injection for 48 weeks treatment plus weight-based Ribavirin orally (1200 mg/kg daily for those \> 75 Kg or 1000mg/Kg daily for those ≤ 75 kg in divided doses). HCV RNA will be assessed at week 12 of initiation of therapy to identify Early Virologic Response (EVR), at week 24 to identify breakthrough viremia, at week 48 to identify End of treatment Response (ETR), and at week 72 to identify Sustained Virologic Response (SVR). All subjects will be followed up during the study as described in the table below (Section 4 Study Design).

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-07-25
• Last updated: 2013-01-15

Locations

1 site across 1 country: Egypt