Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004396
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Studies in Porphyria III Heme and Tin Mesoporphyrin in Acute Porphyrias
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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 Compare the efficacy of heme arginate singly or in combination with tin mesoporphyrin in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria
II Evaluate and compare the safety and tolerability of these treatment regimens in this patient population
II Evaluate and compare the safety and tolerability of these treatment regimens in this patient population
Detailed Description:
PROTOCOL OUTLINE This is an unblinded dose ranging study Patients receive heme arginate alone or in combination with tin mesoporphyrin
Patients receive tin mesoporphyrin IV as a single dose Heme arginate is administered as a single intravenous infusion
Patients are entered in cohorts of 4 Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate Subjects must maintain a constant diet
Patients experiencing adverse reactions are followed as clinically indicated
Patients receive tin mesoporphyrin IV as a single dose Heme arginate is administered as a single intravenous infusion
Patients are entered in cohorts of 4 Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate Subjects must maintain a constant diet
Patients experiencing adverse reactions are followed as clinically indicated
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-96-476 | None | None | None |
| UTMB-96-318 | None | None | None |
| UTMB-FDR000710 | None | None | None |
| UTMB-FDR001459 | None | None | None |