ALFApump System Versus Standard of Care in Ascites Treatment

NCT01528410 | Completed Phase 3 DMC

• 1 other identifier: 2012-AAR-005
• Study Type: interventional
• Target: 58
• Locations: 5 countries
• Sites: 7

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Paracentesis free survival

  Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres

  6 months

Secondary Outcomes (7)

• Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system

  6 months

• Quality of Life

  6 months

• Body weight

  6 months

• Nutritional profile

  6 months

• Resource utilisation

  6 months

Study Arms (2)

ALFApump removal of ascites

EXPERIMENTAL

Removal of ascites

Device: ALFApump removal of ascites

Large volume paracentesis for removal of ascites

ACTIVE COMPARATOR

Removal of ascites

Procedure: Large volume paracentesis for removal of ascites

Interventions

ALFApump removal of ascites DEVICE

Implanted ALFApump, removing produced ascites according to programmed schedule

Also known as: ALFApump (Automated Low Flow Ascites pump)

ALFApump removal of ascites

Large volume paracentesis for removal of ascites PROCEDURE

Large volume paracentesis - standard of care, removing ascites according to patient need

Also known as: Extraction of fluid from the abdominal cavity

Large volume paracentesis for removal of ascites

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 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

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 (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.
• 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

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (7)

Vienna General Hospital and Medical School, AKH

Vienna, Austria

Location

Hopital Beaujon

Clichy, Paris, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29460201 DERIVED

• Bureau 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.

  PMID: 28645737 DERIVED

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajiv Jalan, Professor

  UCL Institute of Hepatology, Royal Free Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be a single center, open-label trial.

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 8, 2012
• Study Start: August 17, 2012
• Primary Completion: September 21, 2016
• Study Completion: September 21, 2016
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

AU (1); FR (2); GB (2); IT (1); ES (1)