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Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia

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ClinicalTrials.gov Identifier: NCT00004327
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Yale University
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


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 or disease Intervention/treatment Phase
Hereditary Hemorrhagic Telangiectasia Ectasia Drug: octreotide Phase 2

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 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 8 participants
Primary Purpose: Treatment
Study Start Date : January 1995

Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004327

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Yale University
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Study Chair: Joshua R. Korzenik Yale University
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ClinicalTrials.gov Identifier: NCT00004327    
Other Study ID Numbers: 199/11875
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2000
Keywords provided by Office of Rare Diseases (ORD):
genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease
senile ectasia
Additional relevant MeSH terms:
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Telangiectasia, Hereditary Hemorrhagic
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents