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.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

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 acetate Octreotide

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

No publications provided

Study ID Numbers:	199/11875, YALESM-7893
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004327 History of Changes
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
Antineoplastic Agents, Hormonal
Cardiovascular Abnormalities
Dilatation, Pathologic
Telangiectasia, Hereditary Hemorrhagic
Hematologic Diseases
Gastrointestinal Diseases
Blood Coagulation Disorders
Gastrointestinal Hemorrhage
Rare Diseases
Vascular Diseases

Octreotide
Hemorrhage
Hemostatic Disorders
Hormones
Somatostatin
Hemorrhagic Disorders
Digestive System Diseases
Vascular Malformations
Telangiectasis
Hereditary Hemorrhagic Telangiectasia
Congenital Abnormalities

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Antineoplastic Agents, Hormonal
Cardiovascular Abnormalities
Dilatation, Pathologic
Antineoplastic Agents
Hematologic Diseases
Telangiectasia, Hereditary Hemorrhagic
Gastrointestinal Diseases
Gastrointestinal Agents
Gastrointestinal Hemorrhage
Vascular Diseases
Octreotide

Hemorrhage
Hemostatic Disorders
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Hemorrhagic Disorders
Therapeutic Uses
Vascular Malformations
Telangiectasis
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 07, 2009