Acute on Chronic Liver FailureHepOnFireNCT05131230
CytoSorb® in Patients With Acute on Chronic Liver Failure
An observational study of Acute on Chronic Liver Failure and Alcoholic Hepatitis, run by CytoSorbents Europe GmbH at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Liver Failure, Alcoholic Hepatitis
- What is being tested?
- CytoSorb® treatment
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Mar 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- Small liver size (diagnosed by imaging, ultrasound/CT)
- Chronic dialysis
- Contraindications for CytoSorb® according to Instructions for Use
- ACLF grade <2
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum, 44892
University of Rostock
Rostock, 18055
About this study
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
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.
- Being tested
- CytoSorb® treatment
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb® treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb group | Not described Receives: Device: CytoSorb® treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131230
- Sponsor's protocol ID
- L02HOF
- Acronym
- HepOnFire
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05131230
- Acronym / sponsor ID
- HepOnFire / L02HOF
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CytoSorbents Europe GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CytoSorb group | – | Device: CytoSorb® treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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:
- Maddrey DF > 32
Key exclusion criteria (10 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb® treatmentPatients 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. | Device | CytoSorb group |
Primary outcome
Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2
Time frame: 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
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute on Chronic Liver Failure and Alcoholic Hepatitis, run by CytoSorbents Europe GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in each group with Acute on Chronic Liver Failure (ACLF) grade <2 (time frame: 7 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.