Overview

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether long-acting octreotide is effective in the treatment of patients with refractory anaemia due to angiodysplasias. The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron infusion requirements in those patients.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Collaborators:
Bernhoven
Bernhoven Hospital
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Gelre Hospitals
Jeroen Bosch Ziekenhuis
Reinier de Graaf Groep
St. Antonius Hospital
VU University Medical Center
Treatments:
Octreotide
Criteria
Inclusion criteria:

- proven angiodysplasias, without any other possible source of gastrointestinal
bleeding.

- transfusion dependency: at least 4 blood transfusions or iron infusions in the year
before inclusion, despite an attempt to supplement iron orally

- failure of endoscopic therapy: at least one endoscopic attempt to coagulate the
angiodysplasias or unsuitable for endoscopic procedures

- providing informed consent

- older than 45 years

Exclusion Criteria:

- age < 45 years

- liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension

- previous unsuccessful treatment with octreotide for the same indication (refractory
anaemia due to angiodysplasias)

- current thalidomide treatment which is effective (no transfusion dependency)

- severe diseases with life expectancy < 1 year

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

- Rendu-Osler-Weber

- pregnancy or nursing women

- uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy

- hereditary hemorrhagic diseases or haematological disorders with active treatment

- patients with a known hypersensitivity to SST analogues or any component of the
sandostatin LAR formulations

- symptomatic cholecystolithiasis

- non-malignant medical illnesses that are uncontrolled or whose control may be
jeopardized by the treatment with this study treatment

- systemic cancer currently undergoing chemotherapy or radiation therapy

- refusal to enter the study

- no understanding of Dutch or English