Acute on Chronic Hepatic FailureHEPATICUS-1NCT01079091
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
A study testing ADVOS (Hepa Wash) and Standard Medical Therapy in people with Acute on Chronic Hepatic Failure, run by Hepa Wash GmbH at 1 site in Germany.
Trial summary
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Hepatic Failure
- What is being tested?
- ADVOS (Hepa Wash) and Standard Medical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Oct 2013
- Phase
- Interventional
- 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
Who may be able to join
- Patients with documented clinical or histological evidence of cirrhosis AND
- Acute decompensation in previously stable cirrhotic liver disease AND
- Bilirubin ≥ 2 mg/dl AND
- SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
- Patient is in the intensive care unit AND
- Informed consent of the patient or the legal representative AND
- Patients are 18y or older AND
- Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)
Who cannot join
- Untreatable extrahepatic cholestasis
- Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.
- PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
- Patients who receive a vasopressor support of Dopamine >15 µg/kg/min or epinephrine >0.1 µg/kg/min or norepinephrine >0.1 µg/kg/min (cardiovascular SOFA-score of 4)
- Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
- Patients on kidney dialysis
Show all 16Show fewer
- Patient with MELD-score of 40
- Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
- Patient testament excludes the use of life-prolonging measures
- Post-operative patients whose liver failure is related to liver surgery
- Uncontrolled seizures
- Active or uncontrolled bleeding
- Weight ≥ 120 kg
- Pregnancy
- Patient diagnosed with Creutzfeldt-Jakob disease
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik, Klinikum rechts der Isar
Munich, Bavaria, 81675
About this study
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care unit.
- Conditions
- Acute on Chronic Hepatic Failure
- Being tested
- ADVOS (Hepa Wash), Standard Medical Therapy
- Keywords
- Liver failure, Hepatic insufficiency, Liver Cirrhosis, Artificial liver, Albumin dialysis
- Medical subject headings
- Liver Failure, Hepatic Insufficiency, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVOS (Hepa Wash)Device
Also called Hepa Wash procedure, the HIP1001 system
Intervention frequency: 1-10 treatments (decision of the investigator)
Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)
Standard Medical TherapyProcedure or surgery
Standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| ADVOS (Hepa Wash) | Experimental | Treatment with the liver support system "Hepa Wash" Receives: Device: ADVOS (Hepa Wash); Procedure: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality rate
Mortality 30 days after the first intervention
Measured: 30 days
Secondary outcomes (6)
Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score
The Sequential Organ Failure Assessment (SOFA) Score analyses the severity of illness according to 6 organ systems (CNS, Liver, Kidney, Hemodynamic, Coagulation, Lung). Each system is given 0 to 4 points for a total of 24 points. A value >2 in each of the systems indicates organ failure. An overall value > 14 indicates 90% probability of in-hospital mortality.
Measured: 72 hours
Safety (adverse events and surrogate parameters)
Adverse Events during the intervention will be assessed. Additionally, liver parameters (e.g. Bilirubin), Kidney Parameters (e.g. Creatinin, Urea) and blood gas analysis will be performed.
Measured: 30 days
Number of days on ventilation
Number of days with need of mechanical ventilation after first intervention
Measured: 30 days
Number of days without extracorporeal treatment
Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
Measured: 30 days
180d-mortality rate
Mortality 180 days after the first intervention
Measured: 180 days
1y-mortality rate
Mortality 1 year after the first intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionOct 2013
Why it stopped: The foundations of our pilotstudy planning has changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute on Chronic Hepatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepa Wash GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Huber, PD Dr., Principal investigator, II Medizinische Klinik, Klinikum rechts der Isar, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079091
- Sponsor's protocol ID
- CS001
- Acronym
- HEPATICUS-1
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2010
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x.
PubMed 28209134
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
- ClinicalTrials.gov ID
- NCT01079091
- Acronym / sponsor ID
- HEPATICUS-1 / CS001
- Conditions
- Acute on Chronic Hepatic Failure
- Keywords
- Liver failure, Hepatic insufficiency, Liver Cirrhosis, Artificial liver, Albumin dialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The foundations of our pilotstudy planning has changed.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hepa Wash GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Mar 2010 (estimated)
- 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.
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADVOS (Hepa Wash) | Experimental | Device: ADVOS (Hepa Wash), Procedure: Standard Medical TherapyTreatment with the liver support system "Hepa Wash" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with documented clinical or histological evidence of cirrhosis AND
- Acute decompensation in previously stable cirrhotic liver disease AND
- Bilirubin ≥ 2 mg/dl AND
- SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
- Patient is in the intensive care unit AND
Key exclusion criteria (16 listed)
- Untreatable extrahepatic cholestasis
- Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.
- PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
- Patients who receive a vasopressor support of Dopamine >15 µg/kg/min or epinephrine >0.1 µg/kg/min or norepinephrine >0.1 µg/kg/min (cardiovascular SOFA-score of 4)
- Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
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 |
|---|---|---|
| ADVOS (Hepa Wash)Also: Hepa Wash procedure, the HIP1001 systemIntervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks) | Device | ADVOS (Hepa Wash) |
| Standard Medical TherapyStandard of care treatment | Procedure or surgery | ADVOS (Hepa Wash) |
Primary outcome
30-day mortality rate
Time frame: 30 days
Mortality 30 days after the first intervention
6 secondary outcomes
Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score
Time frame: 72 hours
Safety (adverse events and surrogate parameters)
Time frame: 30 days
Number of days on ventilation
Time frame: 30 days
Number of days without extracorporeal treatment
Time frame: 30 days
180d-mortality rate
Time frame: 180 days
1y-mortality rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The foundations of our pilotstudy planning has changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Results publication: PubMed 28209134Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x.
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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.
Wolfgang Huber, PD Dr. principal investigator
II Medizinische Klinik, Klinikum rechts der Isar, Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADVOS (Hepa Wash) and Standard Medical Therapy in people with Acute on Chronic Hepatic Failure, run by Hepa Wash GmbH at 1 site 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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 stopped early (reason given: The foundations of our pilotstudy planning has changed.). Results are not available in the source record.
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?
30-day mortality rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079091, which also lists 1 linked publication.
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 5 Jul 2019.