Overview

Alfapump-albumin Replacement Therapy

Status:
Terminated
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Sequana Medical AG
Sequana Medical N.V.
Treatments:
Pharmaceutical Solutions