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

• Status: Unknown status
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MinaPharm Pharmaceuticals
• Treatments: Interferons; Ribavirin

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.