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