Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004398
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
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 Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate
II Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients
II Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients
Detailed Description:
PROTOCOL OUTLINE This is an randomized unblinded multicenter study Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin
Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate Heme arginate is administered daily for 4 days
Patients are followed at 3 and 6 days after treatment
Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate Heme arginate is administered daily for 4 days
Patients are followed at 3 and 6 days after treatment
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 |
|---|---|---|---|
| UTMB-FDR001459 | None | None | None |
| UTMB-97-118 | None | None | None |