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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

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004327
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 2000
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00004327     History of Changes
Other Study ID Numbers: 199/11875, YALESM-7893
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Dilatation, Pathologic
Gastrointestinal Hemorrhage
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013