Back to results

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

Primary Purpose

Hereditary Hemorrhagic Telangiectasia, Ectasia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

octreotide

About this trial

This is an interventional treatment trial for Hereditary Hemorrhagic Telangiectasia focused on measuring genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease, senile ectasia

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004327

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00004327

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2000

Overall Recruitment Status

Completed

Study Start Date

January 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Yale University

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Hemorrhagic Telangiectasia, Ectasia

Keywords

genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease, senile ectasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

8 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

octreotide

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua R. Korzenik

Organizational Affiliation

Yale University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs