Anemia Clinical Trial
Official title:
An Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal Bleeding
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.
Rationale: Rendu-Osler-Weber (ROW) is an autosomal dominant hereditary disease which affects
1 / 5-8000 individuals. It is characterized by arteriovenous malformations (AVMs) and
telangiectasias in multiple organs, including the gastrointestinal tract. Patients can be
transfusion dependent due to severe gastrointestinal bleeding from those telangiectasias.
Endoscopy is not as effective due to the recurrent character of the telangiectasias. Based on
literature in patients with non-ROW AVMs and telangiectasias, octreotide might be beneficial
for these patients to decrease their transfusion needs.
Objective: To assess the efficacy of octreotide in decreasing the need for transfusions and
endoscopic intervention in patients ROW with refractory anaemia due to gastrointestinal
bleeding telangiectasias.
Study design: Multicenter, open-label uncontrolled pilot study.
Study population: Patients with ROW and symptomatic gastrointestinal bleeding
telangiectasias, who are transfusion and/or endoscopy dependent:
1. Transfusion dependent: at least 2 blood and/or iron infusions in the 6 months before
inclusion.
2. Endoscopy dependent: at least one endoscopic intervention with argon plasma coagulation
(APC) after the initial/first endoscopic treatment after diagnosis in the half year
before inclusion or unsuitable for endoscopy.
Intervention: The intervention is 20 mg Sandostatin long-acting release (LAR) once every four
weeks for 26 weeks on top of standard of care.
Main study parameters/endpoints: 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 Important
secondary outcomes are the percent change in the number of rebleeds from baseline to
endpoint and the number of epistaxis episodes.
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