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

NCT01327729 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-04-04

No results posted yet for this study

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)

Conditions

  • Self Efficacy
  • Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    collaborator INDUSTRY

  • BioGeneric Pharma

    lead INDUSTRY

Principal Investigators

  • Gamal Esmat, MD · cairo university - Kasr alaini school of medicine

  • Mohamed Karim F Ashour, MD · Cairo university- Kasr Alaini school of medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-04-30
Completion
2013-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327729 on ClinicalTrials.gov