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

NCT ID: NCT01649245

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Reiferon retard

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Pegylated interferon α 2a

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MinaPharm Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imam Waked, MD

Role: PRINCIPAL_INVESTIGATOR

National Liver Institute, Egypt

Gamal Esmat, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine - Cairo University - Egypt

Hassan Hamdy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine - Ain Shams University - Egypt

Mohamed kohla, MD

Role: STUDY_DIRECTOR

National Liver Institute, Egypt

Locations

National Liver Institute

Shebin El-Kom, Monufia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mohamed Kohla, MD

Role: primary

dr_mohamedsamy@yahoo.com

002048222743

Other Identifiers

HAPIC Trial

Identifier Type: -

Identifier Source: org_study_id