Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01327729
Recruitment Status : Unknown
Verified March 2011 by BioGeneric Pharma.
Recruitment status was:  Recruiting
First Posted : April 4, 2011
Last Update Posted : April 4, 2011
Sponsor:
Collaborator:
Xiamen Amoytop Biotech Co., Ltd.
Information provided by:
BioGeneric Pharma

Tracking Information
First Submitted Date  ICMJE March 31, 2011
First Posted Date  ICMJE April 4, 2011
Last Update Posted Date April 4, 2011
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
Official Title  ICMJE 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
Brief Summary

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)

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Self Efficacy
  • Hepatitis C
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
  • 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
    Intervention: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
  • 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.

    Intervention: Drug: pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 1, 2011)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2013
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01327729
Other Study ID Numbers  ICMJE CHT00234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party prof. dr. mohamed karim, cairo university
Study Sponsor  ICMJE BioGeneric Pharma
Collaborators  ICMJE Xiamen Amoytop Biotech Co., Ltd.
Investigators  ICMJE
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
PRS Account BioGeneric Pharma
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP