Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02339337
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2015-01-12
Brief Title:
A Pilot Study To Evaluate the Efficacy of Response Guided Therapy of Peginterferon Alfa Plus Ribavirin in the Treatment of Patients With HCVHBV Co-Infection
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
A Randomized-Controlled Comparative Study To Evaluate the Efficacy of Tailored Regimen of Peginterferon Alfa Plus Ribavirin According to Rapid Virological Response and Baseline Viral Loads in the Treatment of Patients With Chronic Hepatitis CHepatitis B Co-Infection A Pilot Study Pioneer
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label randomized-controlled comparative trial HBV and HCV dually infected patients with negative hepatitis B e antigen HBeAg were enrolled in the study The definition of HBV and HCV dual infection included seropositivity of HCV antibody anti-HCV and HBsAg for more than 6 months together with positive serum HCV RNA Eligible subjects were randomized into 2 groups at treatment initiation Subjects who were randomized into the genotype guided therapy GGT group received Peg-IFN and standard dose RBV 1200 mgday for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV 800 mgday for 24 weeks in subjects infected with HCV genotype 23 the patients were then followed for 6 months For subjects who were randomized into the response guided therapy RGT group the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1 a pre-treatment low viral load LVL 400000 IUmL and RVR defined asHCV RNA 50 IUmL at 4th week of therapy the duration was 16 weeks in subjects with HCV genotype 23 and RVR
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None