Rendu-Osler-Weber and Hereditary hemorrhagic telangiectasia
Conditions
Interventions
The intervention is 20 mg octreotide LAR once every four weeks for 26 weeks on
top of standard of care.
Sponsors
Maag-, darm- en leverziekten
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with Rendu-Osler-Weber;- Symptomatic gastrointestinal bleeds out of telangiectasias;- Transfusion and / or endoscopy dependent: ;Transfusion: at least 2 blood and/or iron infusions in the 6 months before inclusion.;Endoscopy: at least one endoscopy with APC after the initial endoscopic treatment after diagnosis in the half year before inclusion or unsuitable for endoscopy.
Exclusion criteria
Exclusion criteria: - liver cirrhosis Child-Pugh C or acute liver failure - Symptomatic cholecystolithiasis (without cholecystectomie) - previous unsuccessful treatment with somatostatin analogues for the same indication (refractory anaemia due to telangiectasias) or current effective treatment with a somatostatin analogue - current successful treatment with thalidomide - severe diseases with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is response to treatment defined as: - complete: no endoscopic intervention or transfusion requirements - partial: a reduction in endoscopic intervention or transfusion requirements - non-response: an equal or increase in endoscopy frequency or transfusions | — |
Secondary
| Measure | Time frame |
|---|---|
| Important secondary outcomes are the percent change in the number of rebleeds from baseline to endpoint and the number of epistaxis episodes. | — |
Countries
Netherlands
Outcome results
None listed