The effectiveness of the drug octreotide LAR to anemia in patients with gastrointestinal bleeding due to Rendu-Osler-Weber disease.

Phase 1

• Conditions: Patients with Rendu-Osler-Weber disease (which is also called: Hereditary hemorrhagic telangiectasia); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001340-19-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-11
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

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 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

-liver cirrhosis Child-Pugh C or acute liver failure
-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)
-Symptomatic cholecystolithiasis (without cholecystectomie)
-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 clinical trial of medicinal product
• Study Design: Not specified