HepOnFire: CytoSorb® in Patients With Acute on Chronic Liver Failure

Sponsor

CytoSorbents Europe GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05131230

Collaborator

(none)

Enrollment

Locations

12.6

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and performance of the CytoSorb® therapy in patients with Acute on Chronic Liver Failure (ACLF) grade ≥ 2 due to a severe alcohol induced hepatitis (Maddrey DF > 32) and a severe inflammatory response.

Condition or Disease	Intervention/Treatment	Phase
Acute on Chronic Liver Failure Alcoholic Hepatitis	Device: CytoSorb® treatment

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Prospective, Multi-Centre, Propensity Score Based Matched Pair Controlled, Study of Standard Medical Care Plus CytoSorb® 300 mL Device Compared to Standard Medical Care Alone in Patients With Acute on Chronic Liver Failure Due to Severe Alcoholic Hepatitis in Combination With Systemic Hyperinflammation and Acute on Chronic Liver Failure Score ≥2

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
CytoSorb group	Device: CytoSorb® treatment Patients with Acute on Chronic Liver Failure (ACLF) due to Severe Alcoholic Hepatitis in combination with systemic inflammation and ACLF grade ≥2 will be enrolled in this study. Every patient that is screened, fulfills the inclusion/exclusion criteria, and consents to the study, will be allowed to enter the study. Patients will receive Standard of Care treatment for alcoholic hepatitis plus treatment with the CytoSorb® 300 mL device.

Arm

Intervention/Treatment

CytoSorb group

Device: CytoSorb® treatment

Patients with Acute on Chronic Liver Failure (ACLF) due to Severe Alcoholic Hepatitis in combination with systemic inflammation and ACLF grade ≥2 will be enrolled in this study. Every patient that is screened, fulfills the inclusion/exclusion criteria, and consents to the study, will be allowed to enter the study. Patients will receive Standard of Care treatment for alcoholic hepatitis plus treatment with the CytoSorb® 300 mL device.

Outcome Measures

Primary Outcome Measures

Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2 [7 Days]
To evaluate effectiveness of the CytoSorb® treatment compared to control group by comparing the proportion of patients in each group with ACLF grade <2 at the end of Day 7 after CytoSorb® therapy start (assessed by https://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf).
Safety of CytoSorb treatment [30 Days]
To evaluate if CytoSorb® treatment plus Standard Medical Care (SMC) compared to SMC alone is safe and tolerable as assessed by the incidence of SA(D)Es, ADEs, DDs, SADEs, and USADEs. SAE - Severe Adverse Effect; ADE - Adverse Device Effect; SADE - Severe Adverse Device Effect; DD - Device Deficiencies; USADE - Unexpected Serious Adverse Device Effect

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age≥18
Signed Informed Consent Form (ICF)
Total bilirubin ≥ 8 mg/dL
Acute Alcoholic Hepatitis diagnosed by EtOH consumption within 6 weeks of onset of symptoms, exclusion of other causes for jaundice and liver biopsy or at least 2 out of the following symptoms:

Hepatomegaly
AST > ALT
Elevated WBC
Ascites

Maddrey DF > 32
Systemic inflammation as defined by 2 fulfilled criteria out of:

leucocytosis
body temperature > 38°C
tachycardia > 90 bpm
tachypnoeia > 20 breaths/min

ACLF grade ≥2
Creatinine >2 mg/dl and increase >1.5 mg/dl despite standard of care

Exclusion Criteria:

Platelets < 40,000/mm3
INR > 3.5
MELD Score > 35
AST > 500 IU/l
Bilirubin reduction > 20% in prior 72 hours (early responders to conventional Standard of Care (SOC))
Uncontrolled infection, bleeding or hemodynamic instability
Small liver size (diagnosed by imaging, ultrasound/CT)
Chronic dialysis
Contraindications for CytoSorb® according to Instructions for Use
ACLF grade <2