Clinical trial NCT01649245: Hansenula-derived Pegylated Interferon in Treatment of Patients With Chronic Hepatitis C
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
Egyptian patients
pegylated interferon
Ribavirin
Reiferon retard
Lead sponsor: MinaPharm Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Sustained Virologic Response (SVR)
timeFrame: Assessed 24 weeks after the end of treatment
Secondary outcomes:
measure: Complete Early Virologic Response (cEVR)
timeFrame: At week 12 of therapy
measure: End of Treatment Response (ETR)
timeFrame: at the end of therapy (48 weeks from initiation of therapy
measure: Safety
timeFrame: Throughout the duration of therapy (48weeks)
Other outcomes:
Locations:
city: Shebin El-Kom
country: Egypt
facility: National Liver Institute
state: Menoufiya
Study officials:
affiliation: National Liver Institute, Egypt
name: Imam Waked, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine - Cairo University - Egypt
name: Gamal Esmat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine - Ain Shams University - Egypt
name: Hassan Hamdy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Liver Institute, Egypt
name: Mohamed kohla, MD
role: STUDY_DIRECTOR
References: