Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C (HAPIC)
|ClinicalTrials.gov Identifier: NCT01649245|
Recruitment Status : Unknown
Verified January 2013 by MinaPharm Pharmaceuticals.
Recruitment status was: Recruiting
First Posted : July 25, 2012
Last Update Posted : January 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Reiferon retard||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
Experimental: Reiferon retard plus ribavirin
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
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.
Other Name: Pegylated interferon α 2a
- Sustained Virologic Response (SVR) [ Time Frame: 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.
- Complete Early Virologic Response (cEVR) [ Time Frame: At week 12 of therapy ]Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA at week 12 of therapy.
- End of Treatment Response (ETR) [ Time Frame: at the end of therapy (48 weeks from initiation of therapy ]ETR is defined as undetectable HCV RNA at the end of therapy (at week 48)
- Safety [ Time Frame: Throughout the duration of therapy (48weeks) ]Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649245
|National Liver Institute||Recruiting|
|Shebin El-Kom, Menoufiya, Egypt, 22213|
|Contact: Mohamed Kohla, MD 002048222743 email@example.com|
|Principal Investigator: Imam Waked, MD|
|Sub-Investigator: Mohamed Kohla, MD|
|Principal Investigator:||Imam Waked, MD||National Liver Institute, Egypt|
|Principal Investigator:||Gamal Esmat, MD||Faculty of Medicine - Cairo University - Egypt|
|Principal Investigator:||Hassan Hamdy, MD||Faculty of Medicine - Ain Shams University - Egypt|
|Study Director:||Mohamed kohla, MD||National Liver Institute, Egypt|