Liver CirrhosisNCT02612519
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites
A study testing Alfapump and TIPS in people with Liver Cirrhosis, run by University of Leipzig at 3 sites in Germany.
Trial summary
Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. 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 TIPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2015to 30 Apr 2019
- 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
- Cirrhosis of the liver
- Recurrent or refractory ascites
- Age ≥ 18 years (at informed consent)
- Written informed consent
- Expected ability to operate the Alfapump device
- Alcohol abstinence ≥ 3 months at date of inclusion
Who cannot join
- General contraindications indicating an advanced stage of liver cirrhosis:
- Bilirubin > 5 mg/dl and/or
- INR > 1.5 (without oral anticoagulant such as Vitamin K antagonists or new oral anticoagulants (NOAKs), which inhibit the determination of INR. Therefore patients must be switched to alternative anticoagulants such as heparin or low molecular heparin or fondaparinux that do not interfere with INR measurements) and/or
- Serum-Sodium < 130 mmol/l and/or
- ECOG > 2 (Performance status)
- Gastrointestinal haemorrhage during the last 7 days before inclusion
Show all 19Show fewer
- Renal failure defined as serum creatinine higher than or equal to 1,5 mg/dl at time of inclusion
- 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 before inclusion.
- 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 before inclusion.
- Clinical evidence of loculated ascites.
- Residual urinary volume exceeding 100 ml if obstructive uropathy is known or suspected
- Known bladder anomaly which might contraindicate implantation of the device.
- Known or suspected hepatic or extra hepatic malignancy, unless adequately treated and in complete remission for ≥ 3 years
- Known active chronic hepatitis C (unless adequately treated, i.e no Virus-RNA detectable after cessation of antiviral treatment)
- Acute peritonitis
- Pregnant or nursing women. (A serum pregnancy test is required for fertile women within two years of their last menstruation.)
- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implantation, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
- Suspected lack of compliance
- Patients enrolled in another interventional clinical study
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Medizische Klinik III
Aachen, 52074
Medizinische Klinik und Poliklinik 1 - Gastroenterologie
Dresden, 01307
Uniklinik Leipzig
Leipzig, 04103
About this study
Official title: Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites. A Multicentre Randomised Controlled Study
Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All patients will receive medical care for cirrhosis and ascites according to the institution's standards of care. Standard of care may include, but is not limited to the administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
Read the detailed description
The study will include patients with decompensated liver cirrhosis and recurrent or refractory, with regular requirements for large volume paracentesis (see subject inclusion criteria). With respect to TIPS-contraindications patients will be assigned to two substudies. If no TIPS-contraindications exists (sub-study 1) patients will be randomized to Alfapump or TIPS. The presence of at least one TIPS-contraindication (sub-study 2) is leading to a randomization to Alfapump or standard of care. All patients will receive medical care for cirrhosis and ascites according to the institution's standards medical care. Standard of care may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
- Conditions
- Liver Cirrhosis
- Being tested
- Alfapump, TIPS
- 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
Implantation of Alfapump
TIPSDevice
Implantation of TIPS
| Study group | Role | What they receive |
|---|---|---|
| Alfapump - Substudy 1 | Experimental | Alfapump implantation Receives: Device: Alfapump |
| TIPS - Substudy 1 | Active comparator | TIPS implantation Receives: Device: TIPS |
| Alfapump - Substudy 2 | Experimental | Alfapump implantation Receives: Device: Alfapump |
| Standard - Substudy 2 | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year).
Measured: Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.
Secondary outcomes (10)
Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.
Measured: Starts with randomisation and ends after 24 months or when a device abandonment, transplant, or death occurs before.
Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Transplant-free survival
Measured: From randomisation to 24 months or to death, censoring patients alive at the date of last information or at the date of orthotopic liver transplantation.
Cumulative Incidence of device abandonment
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Volume of ascites removed
Measured: Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.
Patients Quality of Life (EQ-5D Questionnaire)
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Frequency and duration of hospital stays
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Nutrition status, assessed by time course of upper arm girth [cm]
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Albumin substitution, assessed as total amount per quarter [g].
Measured: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher
Measured: Starts with randomisation and ends after 12 months months or when a device abandonment, transplant, or death occurs before.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: low recruitement rate
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelius Engelmann, University of Leipzig
- Investigators
- Thomas Berg, Prof. Dr., Principal investigator, Uniklinik Leipzig Sektion Hepatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612519
- Sponsor's protocol ID
- Agua-Trial
- Status last verified
- Jul 2019
- First submitted
- 11 Nov 2015
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites. A Multicentre Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02612519
- Acronym / sponsor ID
- Agua-Trial
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitement rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 23 Nov 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.
Multicentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All patients will receive medical care for cirrhosis and ascites according to the institution's standards of care. Standard of care may include, but is not limited to the administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
Detailed description
The study will include patients with decompensated liver cirrhosis and recurrent or refractory, with regular requirements for large volume paracentesis (see subject inclusion criteria). With respect to TIPS-contraindications patients will be assigned to two substudies. If no TIPS-contraindications exists (sub-study 1) patients will be randomized to Alfapump or TIPS. The presence of at least one TIPS-contraindication (sub-study 2) is leading to a randomization to Alfapump or standard of care. All patients will receive medical care for cirrhosis and ascites according to the institution's standards medical care. Standard of care may include, but is not limited to, administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alfapump - Substudy 1 | Experimental | Device: AlfapumpAlfapump implantation |
| TIPS - Substudy 1 | Active comparator | Device: TIPSTIPS implantation |
| Alfapump - Substudy 2 | Experimental | Device: AlfapumpAlfapump implantation |
| Standard - Substudy 2 | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cirrhosis of the liver
- Recurrent or refractory ascites
- Age ≥ 18 years (at informed consent)
- Written informed consent
- Expected ability to operate the Alfapump device
Key exclusion criteria (19 listed)
- General contraindications indicating an advanced stage of liver cirrhosis:
- Gastrointestinal haemorrhage during the last 7 days before inclusion
- Renal failure defined as serum creatinine higher than or equal to 1,5 mg/dl at time of inclusion
- 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 before inclusion.
- 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 before inclusion.
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 |
|---|---|---|
| AlfapumpImplantation of Alfapump | Device | Alfapump - Substudy 1, Alfapump - Substudy 2 |
| TIPSImplantation of TIPS | Device | TIPS - Substudy 1 |
Primary outcome
The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year).
Time frame: Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.
10 secondary outcomes
Number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 24 months.
Time frame: Starts with randomisation and ends after 24 months or when a device abandonment, transplant, or death occurs before.
Number of paracenteses per quarter during time without transplant or death documented on a time horizon of 24 months.
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Transplant-free survival
Time frame: From randomisation to 24 months or to death, censoring patients alive at the date of last information or at the date of orthotopic liver transplantation.
Cumulative Incidence of device abandonment
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Volume of ascites removed
Time frame: Starting four weeks after study inclusion and ending after 24 months or when transplant or death occurs before.
Patients Quality of Life (EQ-5D Questionnaire)
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Frequency and duration of hospital stays
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Nutrition status, assessed by time course of upper arm girth [cm]
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Albumin substitution, assessed as total amount per quarter [g].
Time frame: Starts with randomisation and ends after 24 months or when transplant or death occurs before.
Cumulative incidence of first occurrence of hepatic encephalopathy Stage 2 or higher
Time frame: Starts with randomisation and ends after 12 months months or when a device abandonment, transplant, or death occurs before.
Results and safety
The study was stopped early (reason given: low recruitement rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Thomas Berg, Prof. Dr. principal investigator
Uniklinik Leipzig Sektion Hepatologie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfapump and TIPS in people with Liver Cirrhosis, run by University of Leipzig at 3 sites in Germany.
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 6 inclusion and 19 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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: low recruitement rate). 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?
The primary outcome is the (average) number of paracenteses per quarter during time without device abandonment, transplant, or death documented on a time horizon of 4 quarters (i.e.1 year). (time frame: Starts with randomisation and ends after 12 months or when a device abandonment, transplant, or death occurs before.). 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 31 Jul 2019.