Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004436
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Hormonal Regulation of Infantile Hemangioma
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-08
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 clinical efficacy of leuprolide a gonadotropin-releasing hormone agonist GnRHa in treating infants with vision-endangering or large disfiguring hemangiomas
II Assess the impact of GnRHa on growth and development during infancy III Assess the safety of GnHRa in these patients
II Assess the impact of GnRHa on growth and development during infancy III Assess the safety of GnHRa in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized placebo-controlled study Patients are stratified according to gender and by position of the lesion periorbital vs nonperiorbital
All patients receive oral prednisone daily for 3 weeks Patients are then randomized to receive either placebo or leuprolide IM every 3 weeks while continuing oral prednisone Tumors are assessed at 1 3 and 6 weeks If the tumor is not responding the leuprolide will be administered every 2 weeks Tumors are reassessed at 3 and 6 months at which point the treatment is stopped Responding patients are observed every 3 weeks for 3 months If the tumor begins to grow again leuprolide may be administered for another 3 months Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy repeat the leuprolide or prednisone therapy or undergo surgical excision
All patients receive oral prednisone daily for 3 weeks Patients are then randomized to receive either placebo or leuprolide IM every 3 weeks while continuing oral prednisone Tumors are assessed at 1 3 and 6 weeks If the tumor is not responding the leuprolide will be administered every 2 weeks Tumors are reassessed at 3 and 6 months at which point the treatment is stopped Responding patients are observed every 3 weeks for 3 months If the tumor begins to grow again leuprolide may be administered for another 3 months Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy repeat the leuprolide or prednisone therapy or undergo surgical excision
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 |
|---|---|---|---|
| CH-B-FDR000967 | None | None | None |