The effectiveness of Octreotide in hereditary hemorrhagic telangiectasia (a.k.a. Rendu-Osler-Weber disease) patients who suffer from gastrointestinal bleeding.
- Conditions
- Hereditary hemorrhagic telangiectasia (HHT)Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2018-004179-11-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 38
- Patients older than 18 years with written informed consent.
- Diagnosis of HHT: either confirmed by genetic testing or the Curacao criteria (definite
diagnosis).
- Presence of IDA in combination with the presence endoscopic proven GI AVM manifestations /
telangiectasias confirmed within the last 12 months (upper and/or lower endoscopy and/or
capsule endoscopy).
- Endoscopic refractory: at least 1 endoscopic APC / laser /other endoscopic treatment modality
performed in the past 5 years.
- Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6
months prior to study inclusion with a:
o At least one serum ferritin below < 30 ug/l within the last 6 months requiring iron
infusion above or equal to 1 g and/or
o Hemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anemia related symptoms within the last 6 months requiring blood transfusion above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- liver cirrhosis child-pugh C.
- symptomatic cholecystolithiasis (possible side-effect octreotide).
- pregnancy or nursing women or women have a pregnancy wish during the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method