A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anemia Due to Angiodysplasias

NLOCEAN.50514.091.14

The purpose of this study is to determine whether 40 mg octreotide long-acting release intramuscular every 28 days is effective in the treatment of patients with refractory anemia due to gastrointestinal angiodysplasias. We hypothesize that octreotide is effective in reducing the transfusion requirements (consisting of red blood cell transfusions and intravenous iron infusions) of patients with angiodysplasia-related anemia.

2015-09-01

2022-07-01

2023-05-01

Completed

Early phase I

62

Inclusion criteria: * Endoscopically diagnosed angiodysplasias * Transfusion dependency: at least 4 red blood cell transfusions (per 500 ml or packed cells) and/or parental iron infusions (per 500 mg) in the year before inclusion * Failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures * Providing informed consent * Older than 18 years Exclusion Criteria: * Liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension * Previous treatment with octreotide for the same indication (refractory anemia due to angiodysplasias) * Current thalidomide treatment which is effective (no transfusion dependency) * Life expectancy \< 1 year * Left ventricular assist devices (LVAD's) * Hereditary hemorrhagic diseases or hematological disorders with active treatment * Pregnancy or nursing women * Uncontrolled diabetes as defined by HbA1C \>64 mmol/ml, despite adequate therapy * Known hypersensitivity to somatostatin analogs * Symptomatic cholecystolithiasis * Systemic cancer under active treatment (chemotherapy or radiation therapy)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, open-label, randomized, parallel-group, superiority study to compare the efficacy of 40 mg octreotide long-acting release intramuscular every 28 days in addition to standard of care versus standard of care alone in patients with refractory anemia due to gastrointestinal bleeding from angiodysplasias.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The trial was blinded for the outcome adjudication committee but not for patients or attending physicians.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 62, 'type': 'ACTUAL'}}

2023-05-24