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

Primary Purpose

Chronic Hepatitis C

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Reiferon retard

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Egyptian patients, pegylated interferon, Ribavirin, Reiferon retard

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 and < 60.
BMI ≤ 30
Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
F1 stage (by Metavir scoring system) with elevated aminotransferases.
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).
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.
Willing to be treated and to adhere to treatment requirements.

Exclusion Criteria:

Major uncontrolled depressive illness.
Solid organ transplantation.
Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
Untreated thyroid disease.
Pregnant or unwilling to comply with adequate contraception.
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.
Known hypersensitivity to drugs used to treat HCV.

Sites / Locations

National Liver InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reiferon retard plus ribavirin

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complete Early Virologic Response (cEVR)

Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA 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)

Safety

Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported

Full Information

NCT ID

NCT01649245

First Posted

July 20, 2012

Last Updated

January 12, 2013

Sponsor

MinaPharm Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01649245

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MinaPharm Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Egyptian patients, pegylated interferon, Ribavirin, Reiferon retard

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reiferon retard plus ribavirin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Reiferon retard

Other Intervention Name(s)

Pegylated interferon α 2a

Intervention Description

Primary Outcome Measure Information:

Title

Sustained Virologic Response (SVR)

Description

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.

Time Frame

Assessed 24 weeks after the end of treatment

Secondary Outcome Measure Information:

Title

Complete Early Virologic Response (cEVR)

Description

Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA at week 12 of therapy.

Time Frame

At week 12 of therapy

Title

End of Treatment Response (ETR)

Description

ETR is defined as undetectable HCV RNA at the end of therapy (at week 48)

Time Frame

at the end of therapy (48 weeks from initiation of therapy

Title

Safety

Description

Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported

Time Frame

Throughout the duration of therapy (48weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 and < 60. BMI ≤ 30 Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations. F1 stage (by Metavir scoring system) with elevated aminotransferases. 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). 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. Willing to be treated and to adhere to treatment requirements. Exclusion Criteria: Major uncontrolled depressive illness. Solid organ transplantation. Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin. Untreated thyroid disease. Pregnant or unwilling to comply with adequate contraception. 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. Known hypersensitivity to drugs used to treat HCV.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Imam Waked, MD

Organizational Affiliation

National Liver Institute, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gamal Esmat, MD

Organizational Affiliation

Faculty of Medicine - Cairo University - Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hassan Hamdy, MD

Organizational Affiliation

Faculty of Medicine - Ain Shams University - Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed kohla, MD

Organizational Affiliation

National Liver Institute, Egypt

Official's Role

Study Director

Facility Information:

Facility Name

National Liver Institute

City

Shebin El-Kom

State/Province

Menoufiya

ZIP/Postal Code

22213

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Kohla, MD

Phone

002048222743

dr_mohamedsamy@yahoo.com

First Name & Middle Initial & Last Name & Degree

Imam Waked, MD

First Name & Middle Initial & Last Name & Degree

Mohamed Kohla, MD

12. IPD Sharing Statement

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

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