CytoSorb® in Patients With Acute on Chronic Liver Failure

Withdrawn

• Conditions: Acute on Chronic Liver Failure; Alcoholic Hepatitis

• Registration Number: NCT05131230
• Lead Sponsor: CytoSorbents Europe GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-23
• Study Start: 2022-03-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-29
• Primary Completion: 2023-03
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age≥18

2. Signed Informed Consent Form (ICF)

3. Total bilirubin ≥ 8 mg/dL

4. 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

5. Maddrey DF > 32

6. Systemic inflammation as defined by 2 fulfilled criteria out of:

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

7. ACLF grade ≥2

8. Creatinine >2 mg/dl and increase >1.5 mg/dl despite standard of care

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH; 🇩🇪 Bochum, Germany

University of Rostock; 🇩🇪 Rostock, Germany