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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

Phase 2
Completed
Conditions
Rendu-Osler-Weber and Hereditary hemorrhagic telangiectasia
10017959
Registration Number
NL-OMON43279
Lead Sponsor
Maag-, darm- en leverziekten
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
11
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
- no understanding of Dutch or English

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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