Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02099604
Status:
WITHDRAWN
Last Update Posted:
2017-07-12
First Post:
2014-03-24
Brief Title:
Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Efficacy and Safety of the Combination Vitamin D Vit D With Pegylated Interferon Alpha-2b PEG-IFNRibavirin RBV in Egyptian Patients With Untreated Chronic Hepatitis C A Phase III Randomized Open-label Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study objectives were considered as obsolete regarding the new AAD arrival
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViZIR
Brief Summary:
The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN RBV in untreated Egyptian patients with chronic hepatitis C on the sustained virological response SVR at 3 months after end of treatment week 60
Detailed Description:
- Method Phase III randomized open-label superiority clinical trial among Egyptian patients with chronic hepatitis C
- Treatment strategy Vitamin D Arm Vitamin D over a 4 weeks lead-in phase followed by Vitamin D in combination with PEG-INF plus RBV during 48 weeks Standard of Care Arm PEG-INF plus RBV during 48 weeks
- Main outcome Proportion of patients with Sustained Virological Response SVR as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment
Sample Size 520 patients 260 per arm
Enrollment period 12 months
Patients participation duration 62 weeks SOC Arm 66 weeks Vit-D Arm
Statistical analysis
The superiority of the vitamin D arm will be tested against the standard PEG IFN RBV combination 260 patients in each arm will give 80 power to document a 12 difference in the SVR rates between the experimental Vitamin D and the control standard treatment arms
A futility analysis is planned for this study in order to be able to interrupt the trial prematurely in case preliminary results show a lack of efficacy of vitamin D
This analysis will be performed on half of the patients thus 260 patients 130 patients per arm on a week 1214 week criterion HCV RNA viral load at W12W14
- Treatment strategy Vitamin D Arm Vitamin D over a 4 weeks lead-in phase followed by Vitamin D in combination with PEG-INF plus RBV during 48 weeks Standard of Care Arm PEG-INF plus RBV during 48 weeks
- Main outcome Proportion of patients with Sustained Virological Response SVR as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment
Sample Size 520 patients 260 per arm
Enrollment period 12 months
Patients participation duration 62 weeks SOC Arm 66 weeks Vit-D Arm
Statistical analysis
The superiority of the vitamin D arm will be tested against the standard PEG IFN RBV combination 260 patients in each arm will give 80 power to document a 12 difference in the SVR rates between the experimental Vitamin D and the control standard treatment arms
A futility analysis is planned for this study in order to be able to interrupt the trial prematurely in case preliminary results show a lack of efficacy of vitamin D
This analysis will be performed on half of the patients thus 260 patients 130 patients per arm on a week 1214 week criterion HCV RNA viral load at W12W14
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