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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by BioGeneric Pharma.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Xiamen Amoytop Biotech Co., Ltd.
Information provided by:
BioGeneric Pharma
ClinicalTrials.gov Identifier:
NCT01327729
First received: March 31, 2011
Last updated: April 1, 2011
Last verified: March 2011
  Purpose

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)


Condition Intervention Phase
Self Efficacy
Hepatitis C
Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioGeneric Pharma:

Primary Outcome Measures:
  • viral clearance at 72 weeks [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • interferon level [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: November 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327729

Contacts
Contact: Mohamed Karim f Ashour, MD 0020123130102 drmkarim@gmail.com
Contact: Gamal Esmat, MD 002012455468 g_esmat@yahoo.com

Locations
Egypt
Kasr Alaini school of medicne Recruiting
Cairo, Egypt, 11559
Principal Investigator: Mohamed Karim f Ashour, MD         
Sub-Investigator: AMR H ELdeeb, MD         
Sponsors and Collaborators
BioGeneric Pharma
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
  More Information

No publications provided

Responsible Party: prof. dr. mohamed karim, cairo university
ClinicalTrials.gov Identifier: NCT01327729     History of Changes
Other Study ID Numbers: CHT00234
Study First Received: March 31, 2011
Last Updated: April 1, 2011
Health Authority: Egypt: Institutional Review Board
Egypt: Ministry of Health and Population

Keywords provided by BioGeneric Pharma:
pegylated interferon
interferon
HCV
genotype 4

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on April 22, 2014