drugset / Trial / NCT02448160
Alfapump-albumin Replacement Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albumin | Protein / enzyme biologic | 8 g | Intravenous |