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Alfapump-albumin Replacement Therapy

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ClinicalTrials.gov Identifier: NCT02448160
Recruitment Status : Terminated (Recruitment problems)
First Posted : May 19, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sequana Medical N.V.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Device: alfapump Drug: salt-poor Human Albumin solution Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Into the Effects of Albumin Replacement Therapy on Renal and Circulatory Function in Patients Implanted With the Alfapump
Actual Study Start Date : January 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: alfapump with albumin treatment
patients implanted with an alfapump, receiving intermittent salt-poor Human Albumin solution treatment
 Device: alfapump
Implantation of alfapump
Other Name: automated low flow ascites pump

Drug: salt-poor Human Albumin solution
Patients implanted with an alfapump will receive intermittent salt-poor human albumin solution
Other Name: Human albumin


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 3 months ]
    Measured by serum creatinine.


Secondary Outcome Measures :
  1. Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics [ Time Frame: 3 months ]
    Measured by non-invasive cardiac haemodynamics

  2. Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications [ Time Frame: 3 months ]
    Measured by Incidence of specific cirrhosis-related complications

  3. Assessment of the Overall Survival at 3 months, measured by survival [ Time Frame: 3 months ]
    Measured by overall survival at 3 months

  4. Assessment of impact on nutrition, measured by changes in body weight [ Time Frame: 3 months ]
    Measured by changes in the nutritional status of the patient

  5. Assessment of impact on nutrition, measured by changes in circumference of arm [ Time Frame: 3 months ]
    Measured by changes in the nutritional status of the patient

  6. Assessment of impact on nutrition, measured by changes in tricipital skinfold [ Time Frame: 3 months ]
    Measured by changes in the nutritional status of the patient

  7. Assessment of impact on nutrition, measured by changes in handgrip [ Time Frame: 3 months ]
    Measured by changes in the nutritional status of the patient

  8. Assessment of the need for large volume paracentesis, measured by the overall requirements of paracentesis [ Time Frame: 3 months ]
    Measured by the overall requirement for paracentesis

  9. Assessment of impact on Systemic Inflammatory Response, measured by CRP [ Time Frame: 3 months ]
    Measured by Inflammatory markers

  10. Assessment of impact on Systemic Inflammatory Response, measured by cytokines [ Time Frame: 3 months ]
    Measured by Inflammatory markers

  11. Assessment of impact on Systemic Inflammatory Response, measured by function of the peripheral blood mononuclear cells [ Time Frame: 3 months ]
    Measured by Inflammatory markers

  12. Assessment of levels of bacterial DNA in serum, measured by presence of bacterial DNA in blood [ Time Frame: 3 months ]
    Measured by the presence of bacterial DNA in blood.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448160


Locations
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United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Sequana Medical N.V.
Investigators
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Principal Investigator: Rajiv Jalan, Professor Royal Free Hospital NHS Foundation Trust
More Information
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Responsible Party: Sequana Medical N.V.
ClinicalTrials.gov Identifier: NCT02448160    
Other Study ID Numbers: 2015-AAR-009
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases