Alfapump-albumin Replacement Therapy

NCT ID: NCT02448160

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

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 2 weeks) 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.

The primary objective of the study is 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 at the 3-month assessment. This would potentially guide the clinical use of the alfapump system.

The secondary objectives of the study are to address the objectives of a previous alfa pump study /sub study, to allow comparison of the proposed study data to that generated in the previous studies. These will be measured at the 1-month and 3-month time points.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

alfapump with albumin treatment

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

Group Type: EXPERIMENTAL

alfapump

Intervention Type: DEVICE

Implantation of alfapump

salt-poor Human Albumin solution

Intervention Type: DRUG

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

Interventions

alfapump

Implantation of alfapump

Intervention Type: DEVICE

salt-poor Human Albumin solution

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

Intervention Type: DRUG

Other Intervention Names

automated low flow ascites pump; Human albumin

Eligibility Criteria

Inclusion Criteria

1. 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

2. Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria

3. 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).

4. Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

Exclusion Criteria

1. Gastrointestinal haemorrhage over the last 7 days

2. Renal failure defined as serum creatinine higher than or equal to 2 mg/dl

3. Severe coagulopathy defined as prothrombin time greater than 40% more than Upper Limit of Normal

4. Platelet count of less than 40,000 / μL unless platelet therapy is given at the time of surgery

5. 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

6. 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

7. Clinical evidence of loculated ascites

8. Advanced hepatocellular carcinoma, defined as exceeding Milan criteria

9. Obstructive uropathy, residual urinary volume exceeding 100ml, or any bladder anomaly which might contraindicate implantation of the device

10. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to cardiac pacemaker or cardiovertering defibrillator

11. Pregnant females or females anticipating pregnancy during study period

12. Patients currently enrolled in another interventional clinical study

13. Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)

14. Known presence of human immunodeficiency virus (HIV)

15. Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months

16. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years

17. BMI>40 presenting a risk for surgery and tunnelled lines

18. Patients with contraindications for general anesthesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequana Medical N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajiv Jalan, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

Royal Free Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2015-AAR-009

Identifier Type: -

Identifier Source: org_study_id