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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00004327
• Date of registration: 18/10/1999
• Prospective Registration: No
• Primary sponsor: National Center for Research Resources (NCRR)
• Public title: Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia
• Date of first enrolment: January 1995
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00004327
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Joshua R. Korzenik
• Affiliation: Yale University

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ectasia

Hereditary Hemorrhagic Telangiectasia

Intervention(s)

Drug: octreotide

Secondary ID(s)

199/11875

YALESM-7893

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Yale University