drugset / Trial / NCT02448160

Alfapump-albumin Replacement Therapy

NCT02448160

Terminated 10 enrolled Sequana Medical N.V.
NaSingle-groupOpen-labelTreatment

Summary

The study will be a single centre, open-label trial. The patients will have a diagnosis of refractory ascites and will meet specified inclusion/exclusion criteria Informed consent will be obtained from all patients. All patients will have an alfapump surgically inserted and in addition will receive 8g of salt-poor Human Albumin Solution (20%) per 1 litre of Ascites drained. This Intravenous administration will be intermittent (every month) and will take place as a day patient. Patients will also receive standard of care, which may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.

Timeline

Start
2016-01
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 8 g Intravenous

Indications