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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05131230
Other study ID # L02HOF
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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