Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

April 1, 2011 updated by: BioGeneric Pharma

Clinical Trial of the Efficacy, Dosing, Safety and Tolerability of Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV).

Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Methods: Randomized, Open-label trial, in parallel groups (each of 100 patients). Treatment will be given for 48 weeks (positive HCV by polymerase chain reaction (PCR) patients at 24 weeks will be considered non responders) and follow-up for 24 weeks. Total treatment and follow-up duration: 72 weeks. Enrollment duration: 18 months. Total trial duration: 2 years and 9 month, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 300. Precision around the expected efficacy rate (45% in intention-to-treat analysis) will be 9.6% (α = 0.05).

Primary objective: to assess the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.

Secondary objective: To assess the plasma level of the YPEG-IFNα-2a in the first 30 patients in each group, to ensure therapeutic plasma level of the drug at 2 hours, 6 hours, 10 hours, 24 hours, 3 days, 5 days, 7 days, 10 days, 14 days and 28 days.

Treatment strategy:

Three groups in which each group will include 100 patients.

The first group will be treated with:

YPEG-IFN α-2a 180mcg/week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.

The second group will be treated with:

YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.

The third group will be treated with:

YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks. HCV RNA by PCR will be done at 24 weeks and negative PCR patients will continue treatment for another 24 weeks and PCR positive patients will be considered non responders and will be followed up.

Evaluation of the dose efficacy and side effects will be obtained at 4 weeks and 12 weeks of treatment, and any serious side effects or significant dose difference in early virological response in a group will lead to shift of this group to the dose 180 mcg/week.

Main outcome:

Viral clearance by qualitative HCV RNA based on PCR 24 weeks after the end of treatment.

Secondary outcomes:

Evaluation of HCV RNA at 12 and 24 weeks; changes in HCV RNA load during treatment; normalization of ALT during treatment and 24 weeks after the end of treatment; study of side effects; histological changes 24 weeks after the end of treatment: decrease by at least 1 point of the Metavir score.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11559
        • Recruiting
        • Kasr Alaini school of medicne
        • Principal Investigator:
          • Mohamed Karim f Ashour, MD
        • Sub-Investigator:
          • AMR H ELdeeb, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and < 65 years
  • Chronic hepatitis C defined as: HCV antibodies using a third generation test; HCV-RNA positive by PCR; liver biopsy in the past 12 months; METAVIR score of A1 and F0 or higher
  • ALT > 1 ULN in the 24 weeks prior to inclusion (W-26; W-2)
  • Patients never treated with ribavirin, Interferon or PEG-Interferon
  • Normal albumin, prothrombin time > 60%; normal bilirubin
  • Alpha-foeto-protein < 3 times the normal range for the laboratory reference
  • HBs antigen negative
  • Anti Bilharzial antibodies if positive rectal snip shall be done. The examination may be repeated after praziquantel treatment for those with a positive test
  • Hemoglobin > 11g/dl, leucocytes > 3000/mm3, neutrophils > 1500/mm3, platelets > 100 000/mm3, blood creatinin < 1.4 mg/dl
  • Normal TSH (subjects needing treatment to maintain TSH within a normal range may be included if other eligibility criteria are respected)
  • Anti-nuclear antibodies < 1/160
  • Fasting blood sugar between 70-115mg/dl ; if glucose intolerance or diabetes, HbA1C < 8.5%
  • Normal ophthalmologic examination in patients with history of blood pressure and/or diabetes
  • Effective contraception (IUD, diaphragm and spermicide, condoms and spermicides, oral contraceptive, progesterone implants (Norplant), medroxyprogesterone acetate (Depo-provera), tubal ligation, vasectomy) during the treatment period for females. No breastfeeding during the study period
  • Signed informed consent

Exclusion criteria

  • Other liver diseases associated with chronic hepatitis C: co-infection with hepatitis B (positive HBs antigen); hemochromatosis; alpha-1 anti-trypsin deficiency; Wilson disease; alcoholism-related liver disease; Gilbert disease
  • Alcohol intake > 50g/day for males and 40 g/day for females
  • Ongoing intravenous drug use
  • Aggravated liver cirrhosis: history or presence of ascitis, oesophageal varicosis, liver encephalopathy
  • Hepatocellular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: YPEG-IFN α-2a one week
this arm will be treated with: YPEG-IFN α-2a 180mcg/ week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks
Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
Other Names:
  • YPEG-IFN α-2a 180mcg
  • YPEG
  • pegylated interferon
Active Comparator: YPEG-IFN α-2a Ten days
this arm will be treated with: YPEG-IFN α-2a 180mcg/10 days for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks
Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
Other Names:
  • YPEG-IFN α-2a 180mcg
  • YPEG
  • pegylated interferon
Active Comparator: YPEG-IFN α-2a two weeks

The third group will be treated with:

YPEG-IFN α-2a 180mcg/ 2 weeks for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks.
Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
Other Names:
  • YPEG-IFN α-2a 180mcg
  • YPEG
  • pegylated interferon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
viral clearance at 72 weeks
Time Frame: 72 weeks
assessment of the efficacy, dosing, safety and tolerability of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV.
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interferon level
Time Frame: 12 weeks
assessment of the plasma level of the YPEG-IFNα-2a in the first 30 patients in each group, to ensure therapeutic plasma level of the drug at 2 hours, 6 hours, 10 hours, 24 hours, 3 days, 5 days, 7 days, 10 days, 14 days and 28 days.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioGeneric Pharma

Collaborators

Xiamen Amoytop Biotech Co., Ltd.

Investigators

  • Principal Investigator: Gamal Esmat, MD, cairo university - Kasr alaini school of medicine
  • Study Director: Mohamed Karim F Ashour, MD, Cairo university- Kasr Alaini school of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHT00234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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