NCT00004327

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2000

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Hereditary Hemorrhagic TelangiectasiaEctasia

Keywords

genetic diseases and dysmorphic syndromeshematologic disordershereditary hemorrhagic telangiectasiarare diseasesenile ectasia

Interventions

octreotideDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Telangiectasia, Hereditary HemorrhagicDilatation, PathologicGenetic Diseases, InbornHematologic DiseasesRare Diseases

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Joshua R. Korzenik

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

January 1, 1995

Last Updated

June 24, 2005

Record last verified: 2000-06