Liver CirrhosisNCT02448160
Alfapump-albumin Replacement Therapy
A study testing alfapump and salt-poor Human Albumin solution in people with Liver Cirrhosis, run by Sequana Medical N.V. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- alfapump and salt-poor Human Albumin solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
- BMI>40 presenting a risk for surgery and tunnelled lines
- Patients with contraindications for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Into the Effects of Albumin Replacement Therapy on Renal and Circulatory Function in Patients Implanted With the Alfapump
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.
Read the 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
- Being tested
- alfapump, salt-poor Human Albumin solution
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfapumpDevice
Also called automated low flow ascites pump
Implantation of alfapump
salt-poor Human Albumin solutionDrug
Also called Human albumin
Patients implanted with an alfapump will receive intermittent salt-poor human albumin solution
| Study group | Role | What they receive |
|---|---|---|
| alfapump with albumin treatment | Experimental | patients implanted with an alfapump, receiving intermittent salt-poor Human Albumin solution treatment Receives: Device: alfapump; Drug: salt-poor Human Albumin solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (12)
Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics
Measured by non-invasive cardiac haemodynamics
Measured: 3 months
Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications
Measured by Incidence of specific cirrhosis-related complications
Measured: 3 months
Assessment of the Overall Survival at 3 months, measured by survival
Measured by overall survival at 3 months
Measured: 3 months
Assessment of impact on nutrition, measured by changes in body weight
Measured by changes in the nutritional status of the patient
Measured: 3 months
Assessment of impact on nutrition, measured by changes in circumference of arm
Measured by changes in the nutritional status of the patient
Measured: 3 months
Assessment of impact on nutrition, measured by changes in tricipital skinfold
Measured by changes in the nutritional status of the patient
Measured: 3 months
Assessment of impact on nutrition, measured by changes in handgrip
Measured by changes in the nutritional status of the patient
Measured: 3 months
Assessment of the need for large volume paracentesis, measured by the overall requirements of paracentesis
Measured by the overall requirement for paracentesis
Measured: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by CRP
Measured by Inflammatory markers
Measured: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by cytokines
Measured by Inflammatory markers
Measured: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by function of the peripheral blood mononuclear cells
Measured by Inflammatory markers
Measured: 3 months
Assessment of levels of bacterial DNA in serum, measured by presence of bacterial DNA in blood
Measured by the presence of bacterial DNA in blood.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajiv Jalan, Professor, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448160
- Sponsor's protocol ID
- 2015-AAR-009
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2015
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Into the Effects of Albumin Replacement Therapy on Renal and Circulatory Function in Patients Implanted With the Alfapump
- ClinicalTrials.gov ID
- NCT02448160
- Acronym / sponsor ID
- 2015-AAR-009
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alfapump with albumin treatment | Experimental | Device: alfapump, Drug: salt-poor Human Albumin solutionpatients implanted with an alfapump, receiving intermittent salt-poor Human Albumin solution treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alfapumpAlso: automated low flow ascites pumpImplantation of alfapump | Device | alfapump with albumin treatment |
| salt-poor Human Albumin solutionAlso: Human albuminPatients implanted with an alfapump will receive intermittent salt-poor human albumin solution | Drug | alfapump with albumin treatment |
Primary outcome
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.
12 secondary outcomes
Assessment of circulatory haemodynamics, measured by non-invasive cardiac haemodynamics
Time frame: 3 months
Assessment of cirrhosis- related complications, measured by Incidence of specific cirrhosis-related complications
Time frame: 3 months
Assessment of the Overall Survival at 3 months, measured by survival
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in body weight
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in circumference of arm
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in tricipital skinfold
Time frame: 3 months
Assessment of impact on nutrition, measured by changes in handgrip
Time frame: 3 months
Assessment of the need for large volume paracentesis, measured by the overall requirements of paracentesis
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by CRP
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by cytokines
Time frame: 3 months
Assessment of impact on Systemic Inflammatory Response, measured by function of the peripheral blood mononuclear cells
Time frame: 3 months
Assessment of levels of bacterial DNA in serum, measured by presence of bacterial DNA in blood
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Jalan, Professor principal investigator
Royal Free Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alfapump and salt-poor Human Albumin solution in people with Liver Cirrhosis, run by Sequana Medical N.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.