Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055445
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-03-03
Brief Title:
IdB 1016 Treatment for Hepatitis C Disease
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
IdB 1016 in Hepatitis C
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will measure the safety and tolerability of three different doses of IdB 1016 in patients with hepatitis C disease who have not responded to or are poor candidates for interferon-based therapies
NOTE THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL CENTER IN SEATTLE
NOTE THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL CENTER IN SEATTLE
Detailed Description:
Results from two open label and four randomized placebo-controlled studies in patients with liver disease of diverse etiology suggest that IdB 1016 oral silybin-phosphatidylcholine phytosome is well tolerated and significantly improves serum liver enzyme levels However IdB 1016 dosing in these studies ranged from 314 mg bid to 314 mg tid which is below Phase I doses that were well tolerated in healthy volunteers None of the studies tested the safety and efficacy of IdB 1016 strictly in patients with chronic hepatitis C disease or measured post-treatment histologic changes
This study will be an open label randomized dose-finding study There will be three arms corresponding to three different IdB 1016 doses 314 mg 624 mg and 942 mg tid Each arm will have 15 patients diagnosed with chronic hepatitis C and will be stratified to five patients with fibrosis stage II periportal fibrosis five patients with fibrosis stage III bridging fibrosis and five patients with fibrosis stage IV compensated cirrhosis The treatment duration will be 12 weeks Patients will be followed for an additional 4 weeks after treatment cessation to assess residual effects of measured parameters Patients will have clinic visits on Day -21 screening Day 1 treatment initiation Day 29 Day 57 Day 85 end of treatment and Day 113 follow-up after washout
This study will be an open label randomized dose-finding study There will be three arms corresponding to three different IdB 1016 doses 314 mg 624 mg and 942 mg tid Each arm will have 15 patients diagnosed with chronic hepatitis C and will be stratified to five patients with fibrosis stage II periportal fibrosis five patients with fibrosis stage III bridging fibrosis and five patients with fibrosis stage IV compensated cirrhosis The treatment duration will be 12 weeks Patients will be followed for an additional 4 weeks after treatment cessation to assess residual effects of measured parameters Patients will have clinic visits on Day -21 screening Day 1 treatment initiation Day 29 Day 57 Day 85 end of treatment and Day 113 follow-up after washout
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IdB-1016-UW-001 | None | None | None |