Alfapump-albumin Replacement Therapy

NCT02448160 | Terminated

• 1 other identifier: 2015-AAR-009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• To assess whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction, measured by serum creatinine

  Measured by serum creatinine.

  3 months

Secondary Outcomes (12)

• Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics

  3 months

• Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications

  3 months

• Assessment of the Overall Survival at 3 months, measured by survival

  3 months

• Assessment of impact on nutrition, measured by changes in body weight

  3 months

• Assessment of impact on nutrition, measured by changes in circumference of arm

  3 months

Study Arms (1)

alfapump with albumin treatment

EXPERIMENTAL

patients implanted with an alfapump, receiving intermittent salt-poor Human Albumin solution treatment

Device: alfapump; Drug: salt-poor Human Albumin solution

Interventions

alfapump DEVICE

Implantation of alfapump

Also known as: automated low flow ascites pump

alfapump with albumin treatment

salt-poor Human Albumin solution DRUG

Patients implanted with an alfapump will receive intermittent salt-poor human albumin solution

Also known as: Human albumin

alfapump with albumin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤1% failure rate) method of contraception during the course of the study
• Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
• Presenting with refractory ascites\* and requiring periodic large volume paracentesis (large volume defined as ≥ 5 L to accord with the clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
• Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

You may not qualify if:

• Gastrointestinal haemorrhage over the last 7 days
• Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
• Severe coagulopathy defined as prothrombin time greater than 40% more than Upper Limit of Normal
• Platelet count of less than 40,000 / μL unless platelet therapy is given at the time of surgery
• Clinical Evidence of recurrent bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks
• Clinical evidence of recurrent urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks
• Clinical evidence of loculated ascites
• Advanced hepatocellular carcinoma, defined as exceeding Milan criteria
• Obstructive uropathy, residual urinary volume exceeding 100ml, or any bladder anomaly which might contraindicate implantation of the device
• Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardiovertering defibrillator
• Pregnant females or females anticipating pregnancy during study period
• Patients currently enrolled in another interventional clinical study
• Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
• Known presence of human immunodeficiency virus (HIV)
• Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Rajiv Jalan, Professor

  Royal Free Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 19, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

GB (1)