Refractory or Recurrent AscitesPhase 3NCT01528410
ALFApump System Versus Standard of Care in Ascites Treatment
A Phase 3 study testing ALFApump removal of ascites and Large volume paracentesis for removal of ascites in people with Refractory or Recurrent Ascites, run by Sequana Medical N.V. at 7 sites in 5 countries.
Trial summary
This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory or Recurrent Ascites
- What is being tested?
- ALFApump removal of ascites and Large volume paracentesis for removal of ascites
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 17 Aug 2012to 21 Sep 2016
- Phase
- Phase 3
- 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 refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh 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 (as determined locally).
- Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
- Clinical Evidence of recurring 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 recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
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- Clinical evidence of loculated ascites.
- Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
- Obstructive uropathy, residual urinary volume exceeding 100 ml, 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 cardioverter 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 azothioprine, 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 tunneled lines
- Patients with contraindications for general anesthesia
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
France2 sites
Hopital Beaujon
Clichy, Paris
Centre Hospitalier Universitaire de Toulouse
Toulouse
United Kingdom2 sites
Bristol Royal Infirmary
Bristol
Royal Free Hospital
London, NW3 2QG
About this study
Official title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.
- Conditions
- Refractory or Recurrent Ascites
- Being tested
- ALFApump removal of ascites, Large volume paracentesis for removal of ascites
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALFApump removal of ascitesDevice
Also called ALFApump (Automated Low Flow Ascites pump)
Implanted ALFApump, removing produced ascites according to programmed schedule
Large volume paracentesis for removal of ascitesProcedure or surgery
Also called Extraction of fluid from the abdominal cavity
Large volume paracentesis - standard of care, removing ascites according to patient need
| Study group | Role | What they receive |
|---|---|---|
| ALFApump removal of ascites | Experimental | Removal of ascites Receives: Device: ALFApump removal of ascites |
| Large volume paracentesis for removal of ascites | Active comparator | Removal of ascites Receives: Procedure: Large volume paracentesis for removal of ascites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paracentesis free survival
Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres
Measured: 6 months
Secondary outcomes (7)
Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system
Cirrhosis-related complications
Measured: 6 months
Quality of Life
Measured: 6 months
Body weight
Measured: 6 months
Nutritional profile
Measured: 6 months
Resource utilisation
Measured: 6 months
Survival
Measured: 6 months
Assess the need for repeat evacuation paracentesis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study start17 Aug 2012
- Primary completion21 Sep 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory or Recurrent AscitesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a single center, open-label trial.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajiv Jalan, Professor, Principal investigator, UCL Institute of Hepatology, Royal Free Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528410
- Sponsor's protocol ID
- 2012-AAR-005
- Status last verified
- Jun 2017
- First submitted
- 31 Jan 2012
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.
PubMed 29460201Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21.
PubMed 28645737
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT01528410
- Acronym / sponsor ID
- 2012-AAR-005
- Conditions
- Refractory or Recurrent Ascites
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2012 (actual)
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 8 Feb 2012 (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.
This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a single center, open-label trial.
| Arm | Type | Receives |
|---|---|---|
| ALFApump removal of ascites | Experimental | Device: ALFApump removal of ascitesRemoval of ascites |
| Large volume paracentesis for removal of ascites | Active comparator | Procedure: Large volume paracentesis for removal of ascitesRemoval of ascites |
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 refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh 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 (as determined locally).
- Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
- Clinical Evidence of recurring 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 |
|---|---|---|
| ALFApump removal of ascitesAlso: ALFApump (Automated Low Flow Ascites pump)Implanted ALFApump, removing produced ascites according to programmed schedule | Device | ALFApump removal of ascites |
| Large volume paracentesis for removal of ascitesAlso: Extraction of fluid from the abdominal cavityLarge volume paracentesis - standard of care, removing ascites according to patient need | Procedure or surgery | Large volume paracentesis for removal of ascites |
Primary outcome
Paracentesis free survival
Time frame: 6 months
Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis > 5 litres
7 secondary outcomes
Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system
Time frame: 6 months
Quality of Life
Time frame: 6 months
Body weight
Time frame: 6 months
Nutritional profile
Time frame: 6 months
Resource utilisation
Time frame: 6 months
Survival
Time frame: 6 months
Assess the need for repeat evacuation paracentesis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 29460201Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump(R) system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.
- Derived from this study: PubMed 28645737Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21.
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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
UCL Institute of Hepatology, Royal Free Hospital, London
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALFApump removal of ascites and Large volume paracentesis for removal of ascites in people with Refractory or Recurrent Ascites, run by Sequana Medical N.V. at 7 sites in 5 countries.
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: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, United Kingdom, Austria, Italy, Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Paracentesis free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528410, which also lists 2 linked publications.
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 14 Jun 2017.