Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004397
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of 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 effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria
II Evaluate the safety and tolerability of tin mesoporphyrin in these patients
II Evaluate the safety and tolerability of tin mesoporphyrin in these patients
Detailed Description:
PROTOCOL OUTLINE This is an unblinded study Patients start a preventive heme regimen and are followed for 6 months prior to tin mesoporphyrin The frequency of attacks is recorded
Patients receive tin mesoporphyrin once a week for 6 months Patients must avoid sunlight during treatment and for 2 months thereafter The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored
Patients are followed for 6 months after last treatment
Patients receive tin mesoporphyrin once a week for 6 months Patients must avoid sunlight during treatment and for 2 months thereafter The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored
Patients are followed for 6 months after last 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-97-117 | None | None | None |