Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00803309
Status:
TERMINATED
Last Update Posted:
2017-08-28
First Post:
2008-12-04
Brief Title:
Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 23 Patients
Sponsor:
HepNet Study House German Liverfoundation
Organization:
HepNet Study House German Liverfoundation
Study Overview
Official Title:
Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-genotype 2 or 3 12 vs 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
At the end of the planned recruitment period the expected number of subjects could not be included in the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTEX23
Brief Summary:
In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin
The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 15 µgkg PEG-IFN alpha-2b and 800-1400 mg ribavirin standard dose for 24 weeks standard duration and who are not HCV-RNA negative 15 IUml after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment
The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 15 µgkg PEG-IFN alpha-2b and 800-1400 mg ribavirin standard dose for 24 weeks standard duration and who are not HCV-RNA negative 15 IUml after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment
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