Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004804
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1997-02
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:
OBJECTIVES I Determine whether the initial response to interferon alfa IFN-A can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C
II Determine whether patients who had normalized alanine aminotransferase ALT levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 15 MU
II Determine whether patients who had normalized alanine aminotransferase ALT levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 15 MU
Detailed Description:
PROTOCOL OUTLINE Patients are randomly assigned to 1 of 2 treatment groups in a 21 ratio
The first group is treated with high-dose interferon alfa IFN-A administered subcutaneously twice a week for 12 weeks If the alanine aminotransferase ALT level has normalized the IFN-A dose is decreased in a stepwise fashion If the ALT level decreases by more than 50 IFN-A is continued at the same dose until week 24 or the ALT normalizes If the ALT level decreases by less than 50 treatment is discontinued
The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks
The first group is treated with high-dose interferon alfa IFN-A administered subcutaneously twice a week for 12 weeks If the alanine aminotransferase ALT level has normalized the IFN-A dose is decreased in a stepwise fashion If the ALT level decreases by more than 50 IFN-A is continued at the same dose until week 24 or the ALT normalizes If the ALT level decreases by less than 50 treatment is discontinued
The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TUMC-M1260 | None | None | None |