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

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

This study has been completed.

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	8
Study Start Date:	January 1995

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004327

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Yale University

Investigators


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

Keywords provided by Office of Rare Diseases (ORD):

genetic diseases and dysmorphic syndromes

hematologic disorders

hereditary hemorrhagic telangiectasia

rare disease

senile ectasia

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Hereditary hemorrhagic telangiectasia

Cardiovascular Abnormalities

Dilatation, Pathologic

Telangiectasia, Hereditary Hemorrhagic

Hematologic Diseases

Gastrointestinal Diseases

Blood Coagulation Disorders

Gastrointestinal Hemorrhage

Rare Diseases

Vascular Diseases

Octreotide

Hemorrhage

Hemostatic Disorders

Somatostatin

Hemorrhagic Disorders

Digestive System Diseases

Vascular Malformations

Telangiectasis

Congenital Abnormalities

Additional relevant MeSH terms:

Pathologic Processes

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Gastrointestinal Agents

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008