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 (HAPIC)

NCT01649245 Phase 4 UNKNOWN

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.

Details

Lead sponsor	MinaPharm Pharmaceuticals
Phase	Phase 4
Status	UNKNOWN
Enrolment	5000
Start date	2012-08
Completion	2014-08

Conditions

• Chronic Hepatitis C

Interventions

• Reiferon retard

Primary outcomes

• Sustained Virologic Response (SVR) — Assessed 24 weeks after the end of treatment
  Sustained Virologic Response (SVR) is assessed by measurement of HCV RNA viral load 24 weeks after the end of Therapy. SVR is defined as undetectable HCV RNA 24 weeks after the end of therapy.

Countries

Egypt