Clinical Trial: Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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. 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.


Sponsor: Yaqrit Ltd

Current 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Performance of DIALIVE by assessing removal of endotoxins. [ Time Frame: End of DIALIVE treatment (max 10 days after randomization) ]

    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

  • Performance of DIALIVE by assessing removal of albumin. [ Time Frame: End of DIALIVE treatment (max 10 days after randomization) ]

    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)

  • 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 ]

    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)

  • Change in Clinical Parameters by DIALIVE treatment (ACLF grade) between treatment arms. [ Time Frame: Treatment period is from 1 to 10 days post-randomization ]

    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

  • Change in mortality between treatment arms. [ Time Frame: At day 28 post-randomization. ]
    The outcome measure is the difference in mortality between the DIALIVE treatment arm and the Standard of Care arm at day 28 post-randomization.
  • 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 ]

    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)



Original Secondary Outcome: Same as current

Information By: Yaqrit Ltd

Dates:
Date Received: January 18, 2017
Date Started: March 20, 2017
Date Completion: December 2018
Last Updated: March 20, 2017
Last Verified: March 2017