Acute on Chronic Liver FailureDIALIVE _ACLFNCT03065699
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
A study testing DIALIVE Liver Dialysis Device in people with Acute on Chronic Liver Failure, run by Yaqrit Ltd at 12 sites in 8 countries.
Trial summary
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC). Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- DIALIVE Liver Dialysis Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 9 Jul 2017to 15 Jan 2020
- 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years ≤81yr who have given informed consent to participate in the study and are able to understand and comply with the requirements of the study (otherwise written informed consent must be obtained on behalf of the subject in accordance with local ethical and legal requirements).
- History indicative of alcohol-related cirrhosis based on clinical, radiological and/or histological evidence.
- History of an acute decompensating event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening.
- • Subject with :
- ACLF Grade 1, 2 or 3a defined per the CLIF-C OF scoring system OR
- single hepatic organ failure for serum bilirubin > 20 mg/dL (342 µmol/L) at screening and randomization, OR
- AKI-stage 1b (sCr > 1.5 mg/dL or 134 µmol/L).
- Where a subject has received corticosteroids for alcohol-induced ACLF, is unresponsive to at least 7 days of treatment (where lack of response defined as Lille score > 0.45 or steroids stopped before 7 days due to any complication such as infection). This refers to the first course of corticosteroid therapy only.
Who cannot join
- Co-infection with HIV and AIDS defining illness.
- Subjects with acute or sub-acute liver failure without underlying cirrhosis.
- Subjects with severe thrombocytopaenia, defined by the platelet count of < 40,000 / mm3 or rapid reduction in platelet count (> 50% reduction) 24 hrs prior to inclusion.
- Subjects with International Normalised Ratio (INR) > 3
- ACLF 3b patients, i.e. ACLF with more than 3 organ failures.
- Subjects with cirrhosis who develop decompensation at any time in the post-operative period following partial partial liver resection or major non-liver surgery.
Show all 21Show fewer
- Subjects with uncontrolled infection. Patients may be entered into the study provided antimicrobials have been administered for at least 48 hours with an appropriate response observed prior to randomization.
- Subjects with respiratory organ failure (as per CLIF-C OF scoring: PaO2/FiO2< 200 mmHg or 27 kPa or SaO2/FiO2 < 214).
- Subjects with haemodynamic instability:
- persistent hypotension (mean arterial pressure < 65 mmHg) with evidence of tissue hypoperfusion, not responsive to volume resuscitation and/or low dose vasopressor support; ii) a norepinephrine dose of > 0.2 µg/kg/min, or a second pressor (terlipressin for variceal haemorrhage and/or hepato-renal syndrome does not count as pressor, unless it is specifically used to treat systemic hypotension) at screening or randomization. Patients can be reconsidered for study inclusion after at least a 24 hour period of norepinephrine requirement < 0.2 µg/kg/min.
- Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR).
- Subjects with active, or with a history of non hepatic malignancy unless adequately treated or in complete remission for five or more years.
- Patients with HCC outside Milan criteria.
- Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study.
- Subject who has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed.
- Evidence of uncontrolled seizures.
- Subjects diagnosed with Creutzfeldt-Jakob disease.
- In females: known pregnancy or lactating.
- Subjects weighing less than 30 kg (as per contra-indications of oXiris and septeX)
- Where subjectspresent with a known allergy to heparine of have type II thrombocytopaenia caused by heparin (HIT syndrome type II)
- In the opinion of the investigator, it is unsafe for the patient to be considered for the study.
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
United Kingdom3 sites
university hospital BASILDON
Basildon
Royal Free Hospital London NHS
London, Hampstead, NW3 2QG
Queens Medical Centre
Nottingham, NG7 2UH
Spain2 sites
Hospital Clinic Barcelona
Barcelona
University Hospital Gregorio Maragnon
Madrid
About this study
Official title: A Multi-centre, Randomised Controlled Study, to Evaluate the Safety and Performance of The DIALIVE Liver Dialysis Device (LDD) in Patients With Acute on Chronic Liver Failure (ACLF) Versus Standard of Care (SOC)
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).
Read the detailed description
The First-In-Man study will evaluate the safety and performance of DIALIVE Liver Dialysis Device in Acute on Chronic Liver Failure (ACLF) patients and will compare the outcome with patients treated under standard of care (SOC).
The hypothesis is that DIALIVE will significantly improve the prognosis of ACLF patients by modulating systemic inflammation.
The target patient population are men and women ≥18 years, ≤81yr. Patients with ACLF grade 1 and ACLF grade 2 on the background of alcoholic cirrhosis. During the study, inclusion criteria were expanded to include also AKI-1 and ACLF 3a patients. Treatment will be undertaken in an intensive care (ICU) or renal dialysis unit setting if the patients are randomised to the DIALIVE treatment arm. For patients randomised to the 'Standard of care' arm, the location of treatment (ICU or general ward) will be determined by their clinical need and will be decided by the site Principal Investigator.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733057.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- DIALIVE Liver Dialysis Device
- Keywords
- Medical device, Liver dialysis, Haemofilter, ACLF
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIALIVE Liver Dialysis DeviceDevice
Also called YAQ 002
ACLF patients will receive dialysis treatment for 8-12 hrs/day and on three to five consecutive days over a 10-day time period. Dialysis treatment is performed by using the DIALIVE device provided by YAQRIT Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | For patients with ACLF grade 1 or 2 and randomised to the 'Standard of care' arm, the location of treatment (ICU or general ward) will be determined by their clinical need and will be decided by the site Principal Investigator. They will receive standard of care. |
| DIALIVE Liver Dialysis Device treatment arm | Active comparator | Patients with ACLF grade 1 and ACLF grade 2 on the background of alcoholic cirrhosis randomized to the DIALIVE arm will receive treatment in an intensive care (ICU) or renal dialysis unit setting. They will receive DIALIVE treatment according to a fixed treatment schedule over a period of 10 days post-randomization. Receives: Device: DIALIVE Liver Dialysis Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of DIALIVE in terms of percentage of ACLF patients experiencing serious adverse events during DIALIVE treatment period.
To evaluate the safety of the DIALIVE device in patients with Acute on Chronic Liver Failure Grades 1 and 2 (ACLF). Outcome measure is: The percentage of subjects who experience at least one (1) serious adverse event (SAE) between Day 1 and Day 10.(DIALIVE arm only).
Outcome is measured on day 10 and compared between treatment arms.
Measured: Treatment period is from 1 to 10 days post-randomization.
Safety of DIALIVE in terms of percentage of ACLF patients who discontinued treatment due to severe adverse event.
The outcome measure is the percentage of subjects who discontinued DIALIVE treatment due to a serious adverse device event (SADE) between Day 1 (first day of treatment) and Day 10.(DIALIVE arm only)
Measured: Treatment period is from 1 to 10 days post-randomization.
Secondary outcomes (9)
Performance of DIALIVE by assessing removal of endotoxins.
To evaluate the performance of the DIALIVE device in patients with ACLF (DIALIVE arm only). Outcome measure is :
- Change in Plasma endotoxin concentrations between end of treatment with DIALIVE and the beginning of treatment with DIALIVE (Day 1).
TV: 40% reduction; AV: 20% reduction
Measured: End of DIALIVE treatment (max 10 days after randomization)
Performance of DIALIVE by assessing removal of albumin.
To evaluate the performance of the DIALIVE device in patients with ACLF (DIALIVE arm only). Outcome measure is :
- Change in Albumin function (Human non-mercapt albumin -2 (HNA-2) / Human mercapt albumin (HMA ratio) between end of treatment with DIALIVE and the beginning of treatment with DIALIVE (Day 1)
Measured: End of DIALIVE treatment (max 10 days after randomization)
Change in Clinical Parameters by DIALIVE treatment (ACLF grade and score) between treatment arms.
Evaluate the improvement in clinical parameters between Acute on Chronic Liver Failure (ACLF) patients receiving DIALIVE treatment vs Standard of Care. Outcome measure is:
- Change in CLIF-C score (Chronic LIver Failure Consortium)
Measured: Treatment period is from 1 to 10 days post-randomization
Change in Clinical Parameters by DIALIVE treatment (ACLF grade) between treatment arms.
Evaluate the improvement in clinical parameters between Acute on Chronic Liver Failure (ACLF) patients receiving DIALIVE treatment vs Standard of Care. Outcome measure is:
- Change in ACLF Grade
Measured: Treatment period is from 1 to 10 days post-randomization
Change in mortality between treatment arms.
The outcome measure is the difference in mortality between the DIALIVE treatment arm and the Standard of Care arm at day 28 post-randomization.
During the study, the follow up period was prolonged to 90 days (3 months).
Measured: At day 28 post-randomization (for all patients). At day 90 for those patients enrolled under protocol version 6.0.
Change in Clinical Parameters by DIALIVE treatment (CLIF-C score) between treatment arms.
Evaluate the improvement in clinical parameters between Acute on Chronic Liver Failure (ACLF) patients receiving DIALIVE treatment vs Standard of Care. Outcome measure is:
- Change in CLIF-C score (Chronic LIver Failure Consortium)
Measured: Treatment period is from 1 to 10 days post-randomization
Status of ICU and hospital discharge.
Location of patient at day 28 and 90 post randomization, and timing of discharge from hospital.
Measured: Treatment period is from 1 to 90 days post-randomization.
Length of stay in ICU and in hospital
Evaluation of length of stay of patient in the hospital and on the ICU.
Measured: Assessment is done on day 28 and day 90.
ICU and hospital re-adminssions with another episode of ACLF
Assessment of re-admissions of patients for another episode of ACLF after hospital discharge post-randomization.
Measured: Assessment is done on day 28 and day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start9 Jul 2017
- Primary completion31 Dec 2019
- Study completion15 Jan 2020
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 Acute on Chronic Liver FailureStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety (as measured by the percentage of subjects who experience at least one serious adverse event (SAE)) and performance (as measured by lowering of the plasma endotoxin concentrations, and improved albumin function) of DIALIVE in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC). During the study the sample size was increased to include a total 30 evaluable patients.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaqrit Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Foundation for Chronic Liver Failure, University College, London, Fakkel bvba
- Responsible party
- Sponsor
- Investigators
- Banwari Agarwal, Dr, Principal investigator, Royal Free Hospital London NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065699
- Sponsor's protocol ID
- YAQ-002
- Other IDs
- CIV-16-08-016644
- Acronym
- DIALIVE _ACLF
- Status last verified
- May 2021
- First submitted
- 18 Jan 2017
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymized clinical data can be shared out of central database according to the H2020 project plan.
Publications
Lee KC, Baker LA, Stanzani G, Alibhai H, Chang YM, Jimenez Palacios C, Leckie PJ, Giordano P, Priestnall SL, Antoine DJ, Jenkins RE, Goldring CE, Park BK, Andreola F, Agarwal B, Mookerjee RP, Davies NA, Jalan R. Extracorporeal liver assist device to exchange albumin and remove endotoxin in acute liver failure: Results of a pivotal pre-clinical study. J Hepatol. 2015 Sep;63(3):634-42. doi: 10.1016/j.jhep.2015.04.020. Epub 2015 May 1.
PubMed 25937432Agarwal B, Canizares RB, Saliba F, Ballester MP, Tomescu DR, Martin D, Stadlbauer V, Wright G, Sheikh M, Morgan C, Alzola C, Lavin P, Green D, Kumar R, Sacleux SC, Schilcher G, Koball S, Tudor A, Minten J, Domenech G, Aragones JJ, Oettl K, Paar M, Waterstradt K, Bode-Boger SM, Ibanez-Samaniego L, Gander A, Ramos C, Chivu A, Stange J, Lamprecht G, Sanchez M, Mookerjee RP, Davenport A, Davies N, Pavesi M, Andreola F, Albillos A, Cordingley J, Schmidt H, Carbonell-Asins JA, Arroyo V, Fernandez J, Mitzner S, Jalan R. Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure. J Hepatol. 2023 Jul;79(1):79-92. doi: 10.1016/j.jhep.2023.03.013. Epub 2023 May 31.
PubMed 37268222
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised Controlled Study, to Evaluate the Safety and Performance of The DIALIVE Liver Dialysis Device (LDD) in Patients With Acute on Chronic Liver Failure (ACLF) Versus Standard of Care (SOC)
- ClinicalTrials.gov ID
- NCT03065699
- Acronym / sponsor ID
- DIALIVE _ACLF / YAQ-002
- Conditions
- Acute on Chronic Liver Failure
- Keywords
- Medical device, Liver dialysis, Haemofilter, ACLF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yaqrit LtdIndustry (pharma, biotech, devices)
- Collaborators
- European Foundation for Chronic Liver Failure, University College, London, Fakkel bvba
- Study start
- 9 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- 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 First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).
Detailed description
The First-In-Man study will evaluate the safety and performance of DIALIVE Liver Dialysis Device in Acute on Chronic Liver Failure (ACLF) patients and will compare the outcome with patients treated under standard of care (SOC).
The hypothesis is that DIALIVE will significantly improve the prognosis of ACLF patients by modulating systemic inflammation.
The target patient population are men and women ≥18 years, ≤81yr. Patients with ACLF grade 1 and ACLF grade 2 on the background of alcoholic cirrhosis. During the study, inclusion criteria were expanded to include also AKI-1 and ACLF 3a patients. Treatment will be undertaken in an intensive care (ICU) or renal dialysis unit setting if the patients are randomised to the DIALIVE treatment arm. For patients randomised to the 'Standard of care' arm, the location of treatment (ICU or general ward) will be determined by their clinical need and will be decided by the site Principal Investigator.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733057.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety (as measured by the percentage of subjects who experience at least one serious adverse event (SAE)) and performance (as measured by lowering of the plasma endotoxin concentrations, and improved albumin function) of DIALIVE in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC). During the study the sample size was increased to include a total 30 evaluable patients.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –For patients with ACLF grade 1 or 2 and randomised to the 'Standard of care' arm, the location of treatment (ICU or general ward) will be determined by their clinical need and will be decided by the site Principal Investigator. They will receive standard of care. |
| DIALIVE Liver Dialysis Device treatment arm | Active comparator | Device: DIALIVE Liver Dialysis DevicePatients with ACLF grade 1 and ACLF grade 2 on the background of alcoholic cirrhosis randomized to the DIALIVE arm will receive treatment in an intensive care (ICU) or renal dialysis unit setting. They will receive DIALIVE treatment according to a fixed treatment schedule over a period of 10 days post-randomization. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥18 years ≤81yr who have given informed consent to participate in the study and are able to understand and comply with the requirements of the study (otherwise written informed consent must be obtained on behalf of the subject in accordance with local ethical and legal requirements).
- History indicative of alcohol-related cirrhosis based on clinical, radiological and/or histological evidence.
- History of an acute decompensating event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening.
- • Subject with :
- Where a subject has received corticosteroids for alcohol-induced ACLF, is unresponsive to at least 7 days of treatment (where lack of response defined as Lille score > 0.45 or steroids stopped before 7 days due to any complication such as infection). This refers to the first course of corticosteroid therapy only.
Key exclusion criteria (21 listed)
- Co-infection with HIV and AIDS defining illness.
- Subjects with acute or sub-acute liver failure without underlying cirrhosis.
- Subjects with severe thrombocytopaenia, defined by the platelet count of < 40,000 / mm3 or rapid reduction in platelet count (> 50% reduction) 24 hrs prior to inclusion.
- Subjects with International Normalised Ratio (INR) > 3
- ACLF 3b patients, i.e. ACLF with more than 3 organ failures.
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 |
|---|---|---|
| DIALIVE Liver Dialysis DeviceAlso: YAQ 002ACLF patients will receive dialysis treatment for 8-12 hrs/day and on three to five consecutive days over a 10-day time period. Dialysis treatment is performed by using the DIALIVE device provided by YAQRIT Ltd. | Device | DIALIVE Liver Dialysis Device treatment arm |
Primary outcome
Safety of DIALIVE in terms of percentage of ACLF patients experiencing serious adverse events during DIALIVE treatment period.
Time frame: Treatment period is from 1 to 10 days post-randomization.
To evaluate the safety of the DIALIVE device in patients with Acute on Chronic Liver Failure Grades 1 and 2 (ACLF). Outcome measure is: The percentage of subjects who experience at least one (1) serious adverse event (SAE) between Day 1 and Day 10.(DIALIVE arm only). Outcome is measured on day 10 and compared between treatment arms.
Safety of DIALIVE in terms of percentage of ACLF patients who discontinued treatment due to severe adverse event.
Time frame: Treatment period is from 1 to 10 days post-randomization.
The outcome measure is the percentage of subjects who discontinued DIALIVE treatment due to a serious adverse device event (SADE) between Day 1 (first day of treatment) and Day 10.(DIALIVE arm only)
9 secondary outcomes
Performance of DIALIVE by assessing removal of endotoxins.
Time frame: End of DIALIVE treatment (max 10 days after randomization)
Performance of DIALIVE by assessing removal of albumin.
Time frame: End of DIALIVE treatment (max 10 days after randomization)
Change in Clinical Parameters by DIALIVE treatment (ACLF grade and score) between treatment arms.
Time frame: Treatment period is from 1 to 10 days post-randomization
Change in Clinical Parameters by DIALIVE treatment (ACLF grade) between treatment arms.
Time frame: Treatment period is from 1 to 10 days post-randomization
Change in mortality between treatment arms.
Time frame: At day 28 post-randomization (for all patients). At day 90 for those patients enrolled under protocol version 6.0.
Change in Clinical Parameters by DIALIVE treatment (CLIF-C score) between treatment arms.
Time frame: Treatment period is from 1 to 10 days post-randomization
Status of ICU and hospital discharge.
Time frame: Treatment period is from 1 to 90 days post-randomization.
Length of stay in ICU and in hospital
Time frame: Assessment is done on day 28 and day 90.
ICU and hospital re-adminssions with another episode of ACLF
Time frame: Assessment is done on day 28 and day 90.
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 1 Jun 2021.
- Background: PubMed 25937432Lee KC, Baker LA, Stanzani G, Alibhai H, Chang YM, Jimenez Palacios C, Leckie PJ, Giordano P, Priestnall SL, Antoine DJ, Jenkins RE, Goldring CE, Park BK, Andreola F, Agarwal B, Mookerjee RP, Davies NA, Jalan R. Extracorporeal liver assist device to exchange albumin and remove endotoxin in acute liver failure: Results of a pivotal pre-clinical study. J Hepatol. 2015 Sep;63(3):634-42. doi: 10.1016/j.jhep.2015.04.020. Epub 2015 May 1.
- Derived from this study: PubMed 37268222Agarwal B, Canizares RB, Saliba F, Ballester MP, Tomescu DR, Martin D, Stadlbauer V, Wright G, Sheikh M, Morgan C, Alzola C, Lavin P, Green D, Kumar R, Sacleux SC, Schilcher G, Koball S, Tudor A, Minten J, Domenech G, Aragones JJ, Oettl K, Paar M, Waterstradt K, Bode-Boger SM, Ibanez-Samaniego L, Gander A, Ramos C, Chivu A, Stange J, Lamprecht G, Sanchez M, Mookerjee RP, Davenport A, Davies N, Pavesi M, Andreola F, Albillos A, Cordingley J, Schmidt H, Carbonell-Asins JA, Arroyo V, Fernandez J, Mitzner S, Jalan R. Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure. J Hepatol. 2023 Jul;79(1):79-92. doi: 10.1016/j.jhep.2023.03.013. Epub 2023 May 31.
- webpage legal responsible partner \& spnosorLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only anonymized clinical data can be shared out of central database according to the H2020 project plan.
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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.
Banwari Agarwal, Dr principal investigator
Royal Free Hospital London NHS
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIALIVE Liver Dialysis Device in people with Acute on Chronic Liver Failure, run by Yaqrit Ltd at 12 sites in 8 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 8 inclusion and 21 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 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, France, Spain, Austria, Belgium and 3 more countries. 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 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?
Safety of DIALIVE in terms of percentage of ACLF patients experiencing serious adverse events during DIALIVE treatment period. (time frame: Treatment period is from 1 to 10 days post-randomization.). The study lists 2 primary outcomes in all. 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 NCT03065699, 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 1 Jun 2021.