NL-OMON43279
Completed
Phase 2
An uncontrolled, pilot-study assessing the efficacy of octreotide LAR to decrease transfusion requirements and endoscopy frequency in patients with Rendu-Osler-Weber and gastrointestinal bleeding - ROW
Maag-, darm- en leverziekten0 sites11 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rendu-Osler-Weber and Hereditary hemorrhagic telangiectasia
- Sponsor
- Maag-, darm- en leverziekten
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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
- •\- 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 \< 1 year
- •\- patients with left ventricular assist devices (LVAD\*s)
- •\- pregnancy or nursing women or women who have a pregnancy wish in the studyperiod or who use anticonception inadequate
- •\- current chemotherapy
- •\- patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR formulations
- •\- systemic cancer currently undergoing chemotherapy or radiation therapy
Outcomes
Primary Outcomes
Not specified
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