Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004327
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Pilot Study of Octreotide a Somatostatin Octapeptide Analog for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia
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 octreotide a somatostatin octapeptide analog in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia
I Evaluate the efficacy of octreotide a somatostatin octapeptide analog in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia
Detailed Description:
PROTOCOL OUTLINE Patients are treated with subcutaneous injections of octreotide twice a day The dose is adjusted based on response
If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mgdL therapy is continued for 1 year If there is no decrease in bleeding after 10 weeks the patient is removed from study
If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mgdL therapy is continued for 1 year If there is no decrease in bleeding after 10 weeks the patient is removed from study
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 |
|---|---|---|---|
| YALESM-7893 | None | None | None |