CytoSorb® in Patients With Acute on Chronic Liver Failure

Alcoholic Hepatitis Clinical Trial

— HepOnFire  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05131230
• Other study ID #: L02HOF
• Status: Withdrawn
• Start date: March 15, 2022
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: CytoSorbents Europe GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• Alcoholic Hepatitis
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatitis
• Hepatitis, Alcoholic
• Liver Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH	Bochum
Germany	University of Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
CytoSorbents Europe GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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