Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether long-acting octreotide is safe and effective in the treatment of patients with Rendu-Osler-Weber (e.g. HHT).

The study hypothesis is that octreotide is safe and will reduce transfusion requirements and endoscopy frequency in ROW patients with refractory anaemia due to bleeding gastrointestinal telangiectasias.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: St. Antonius Hospital
• Treatments: Octreotide

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 endoscopic therapy.

Exclusion Criteria:

• liver cirrhosis Child-Pugh C or acute liver failure

• previous unsuccessful treatment with somatostatin analogues (SST) for the same indication (refractory anaemia due to telangiectasias) or current effective treatment with a somatostatin analogue

• severe diseases with life expectancy < 1 year

• patients with left ventricular assist devices (LVAD's)

• Symptomatic cholecystolithiasis (without cholecystectomy)

• pregnancy or nursing women or women who have a pregnancy wish in the study period or who use anticonception inadequate

• current chemotherapy

• patients with a known hypersensitivity to SST analogues or any component of the octreotide LAR formulations

• no understanding of Dutch or English