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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Yale University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004327 |
Purpose
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.
| Condition | Intervention | Phase |
|
Hereditary Hemorrhagic Telangiectasia Ectasia |
Drug: octreotide |
Phase II |
| Genetics Home Reference related topics: | hemophilia hereditary hemorrhagic telangiectasia |
| MedlinePlus related topics: | Gastrointestinal Bleeding |
| Drug Information available for: | Octreotide Octreotide acetate Somatostatin |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 8 |
| Study Start Date: | January 1995 |
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 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Hereditary hemorrhagic telangiectasia or senile ectasia Refractory to or unable to tolerate hormonal therapy, i.e.: Estrogen Progesterone Danazol Gastrointestinal (GI) hemorrhage requiring transfusion within past 3 months Recurrent GI bleeding over more than 1 year At least 4 units packed RBCs transfused within past year OR intravenous iron required more than 4 times within past year No other likely source of hemorrhage determined within past year --Prior/Concurrent Therapy-- Disease hormone-refractory --Patient Characteristics-- No octreotide sensitivity
Contacts and Locations| National Center for Research Resources (NCRR) |
| Yale University |
| Study Chair: | Joshua R. Korzenik | Yale University |
More Information
| Study ID Numbers: | 199/11875, YALESM-7893 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004327 |
| Health Authority: | United States: Federal Government |
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