CytoSorb® in Patients With Acute on Chronic Liver Failure

NCT05131230 | Withdrawn

• 1 other identifier: L02HOF
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute on Chronic Liver Failure; Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2

  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).

  7 Days

• Safety of CytoSorb treatment

  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

  30 Days

Study Arms (1)

CytoSorb group

Device: CytoSorb® treatment

Interventions

CytoSorb® treatment DEVICE

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.

CytoSorb group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients meeting the eligibility requirements of the study will receive Standard of Care treatment for alcoholic hepatitis (including steroid therapy according to AASLD/EASL guidelines and extracorporeal treatments when indicated) plus treatment with the CytoSorb® 300 mL device, a hemoperfusion adsorbent CE-certified therapy for the removal of bilirubin and pro-inflammatory cytokines (CytoSorb group). 30 propensity score matched controls from a patient database will be drawn from existing US and European sources (prospectively collected databases from geographies with comparable Standard of Care). The 30 CytoSorb group patients will be compared with these database patients.

You may qualify if:

• Age≥18
• Signed Informed Consent Form (ICF)
• Total bilirubin ≥ 8 mg/dL
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CytoSorbents Europe GmbH: lead

Study Sites (2)

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, 44892, Germany

Location

University of Rostock

Rostock, 18055, Germany

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Hepatitis; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 23, 2021
• Study Start: March 15, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

DE (2)