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
Sponsor study identifier
interventional
300
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 31, 2011
Actual (reported)April 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 4, 2011
Actual (reported)May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
viral clearance at 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
interferon level
12 weeks
this arm will be treated with: YPEG-IFN α-2a 180mcg/ week for 48 weeks. Ribavirin 15 mg/kg/day for 48 weeks
this arm 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.
YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kasr Alaini school of medicne
Cairo, Cairo Governorate, 11559, Egypt
Gamal Esmat, MD
cairo university - Kasr alaini school of medicine
Mohamed Karim F Ashour, MD
Cairo university- Kasr Alaini school of medicine
First Submitted
March 31, 2011
First Posted
April 4, 2011
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 4, 2011
Record last verified: 2011-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: