Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by MinaPharm Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
MinaPharm Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01649245
First received: July 20, 2012
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Reiferon retard
Phase 4

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

Resource links provided by NLM:


Further study details as provided by MinaPharm Pharmaceuticals:

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) [ Time Frame: Assessed 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

    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) [ Time Frame: At week 12 of therapy ] [ Designated as safety issue: No ]
    Complete Early Virologic Response (cEVR)is defined as undetectable HCV RNA at week 12 of therapy.

  • End of Treatment Response (ETR) [ Time Frame: at the end of therapy (48 weeks from initiation of therapy ] [ Designated as safety issue: No ]
    ETR is defined as undetectable HCV RNA at the end of therapy (at week 48)

  • Safety [ Time Frame: Throughout the duration of therapy (48weeks) ] [ Designated as safety issue: Yes ]
    Drug safety will be monitored throughout the treatment duration (48 weeks), and any moderate to severe adverse events will be reported


Estimated Enrollment: 5000
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
Other Name: Pegylated interferon α 2a

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649245

Locations
Egypt
National Liver Institute Recruiting
Shebin El-Kom, Menoufiya, Egypt, 22213
Contact: Mohamed Kohla, MD    002048222743    dr_mohamedsamy@yahoo.com   
Principal Investigator: Imam Waked, MD         
Sub-Investigator: Mohamed Kohla, MD         
Sponsors and Collaborators
MinaPharm Pharmaceuticals
Investigators
Principal Investigator: Imam Waked, MD National Liver Institute, Egypt
Principal Investigator: Gamal Esmat, MD Faculty of Medicine - Cairo University - Egypt
Principal Investigator: Hassan Hamdy, MD Faculty of Medicine - Ain Shams University - Egypt
Study Director: Mohamed kohla, MD National Liver Institute, Egypt
  More Information

No publications provided

Responsible Party: MinaPharm Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01649245     History of Changes
Other Study ID Numbers: HAPIC Trial
Study First Received: July 20, 2012
Last Updated: January 12, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by MinaPharm Pharmaceuticals:
Chronic hepatitis C
Egyptian patients
pegylated interferon
Ribavirin
Reiferon retard

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014