- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004327
Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Joshua R. Korzenik, Yale University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Telangiectasis
- Dilatation, Pathologic
- Telangiectasia, Hereditary Hemorrhagic
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
Other Study ID Numbers
- 199/11875
- YALESM-7893
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Hemorrhagic Telangiectasia
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Vaderis Therapeutics AGRecruitingHereditary Hemorrhagic Telangiectasia (HHT)United States, Spain, France, Belgium, Netherlands, Italy
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Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia (HHT)United Kingdom
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University Hospital, EssenCompletedHereditary Haemorrhagic Telangiectasia (HHT)Germany
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University of PennsylvaniaCompletedHereditary Hemorrhagic Telangiectasia (HHT)United States
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Centre Hospitalier Universitaire DijonCompletedHereditary Hemorrhagic TelangiectasiaFrance
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Hospices Civils de LyonCompletedHHT | Hemorrhagic Hereditary TelangiectasiaFrance
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Unity Health TorontoThe Hospital for Sick Children; Sunnybrook Health Sciences Centre; National Institute... and other collaboratorsCompletedHereditary Hemorrhagic TelangiectasiaCanada
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Fondazione Policlinico Universitario Agostino Gemelli...CompletedHereditary Hemorrhagic TelangiectasiaItaly
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Novartis PharmaceuticalsCompletedChemotherapy-induced DiarrheaBrazil
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Qilu Pharmaceutical Co., Ltd.CompletedHealthy VolunteersChina
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Peking UniversityUnknownEsophageal Neuroendocrine Carcinoma | Gastro-entero-pancreatic CarcinomaChina
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Azidus BrasilSuspended
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Cliniques universitaires Saint-Luc- Université...TerminatedNeuroendocrine Tumors | Carcinoid Syndrome