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

Chronic Hepatitis C Clinical Trial

— HAPIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01649245
• Other study ID #: HAPIC Trial
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2012
• Last updated: January 12, 2013
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: January 2013
• Source: MinaPharm Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
Egypt	National Liver Institute	Shebin El-Kom	Menoufiya

Sponsors (1)

Lead Sponsor	Collaborator
MinaPharm Pharmaceuticals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes