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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: Reiferon retard

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).

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufiya
    • Shebin El-Kom, Menoufiya, Egypt, 22213
      • Recruiting
      • National Liver Institute
      • Contact: Mohamed Kohla, MD; Phone Number: 002048222743; Email: dr_mohamedsamy@yahoo.com
      • Principal Investigator: Imam Waked, MD
      • Sub-Investigator: Mohamed Kohla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 18 and < 60.
2. BMI ≤ 30
3. Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
4. F1 stage (by Metavir scoring system) with elevated aminotransferases.
5. Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
6. Acceptable hematological and biochemical indices (hemoglobin ≥ 11g/dl; total leukocytic count ≥ 3000/cmm, absolute neutrophil count ≥ 1500/cmm and serum creatinine < 1.97 mg/dl.
7. Willing to be treated and to adhere to treatment requirements.

Exclusion Criteria:

1. Major uncontrolled depressive illness.
2. Solid organ transplantation.
3. Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
4. Untreated thyroid disease.
5. Pregnant or unwilling to comply with adequate contraception.
6. Severe concurrent medical disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes (HbA1C > 8.5 %), and chronic obstructive pulmonary disease.
7. Known hypersensitivity to drugs used to treat HCV.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Pegylated interferon α 2a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Virologic Response (SVR)	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.	Assessed 24 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Early Virologic Response (cEVR)	Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA at week 12 of therapy.	At week 12 of therapy
End of Treatment Response (ETR)	ETR is defined as undetectable HCV RNA at the end of therapy (at week 48)	at the end of therapy (48 weeks from initiation of therapy
Safety	Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported	Throughout the duration of therapy (48weeks)

Collaborators and Investigators

• Sponsor: MinaPharm Pharmaceuticals
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 12, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Chronic hepatitis C; Ribavirin; Egyptian patients; pegylated interferon; Reiferon retard
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons
• Other Study ID Numbers: HAPIC Trial