Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units (HEPATICUS-1)

This study has been terminated.
(The foundations of our pilotstudy planning has changed.)
Information provided by (Responsible Party):
Hepa Wash GmbH
ClinicalTrials.gov Identifier:
First received: March 1, 2010
Last updated: December 30, 2014
Last verified: December 2014
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.

Condition Intervention
Acute on Chronic Hepatic Failure
Device: Hepa Wash
Procedure: Standard Medical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

Further study details as provided by Hepa Wash GmbH:

Primary Outcome Measures:
  • 30-day mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multiorgan system failure [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Safety (surrogate parameters) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Number of days on ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of days without extracorporeal treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 180d-mortality rate [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • 1y-mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Standard Medical Therapy
Procedure: Standard Medical Therapy
Standard of care treatment
Experimental: Hepa Wash
Treatment with the liver support system "Hepa Wash"
Device: Hepa Wash

Intervention frequency: 1-10 treatments (decision of the investigator)

Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)

Other Names:
  • Hepa Wash procedure
  • the HIP1001 system


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with documented clinical or histological evidence of cirrhosis AND
  2. Acute decompensation in previously stable cirrhotic liver disease AND
  3. Bilirubin ≥ 2 mg/dl AND
  4. SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
  5. Patient is in the intensive care unit AND
  6. Informed consent of the patient or the legal representative AND
  7. Patients are 18y or older AND
  8. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)

Exclusion Criteria:

  1. Untreatable extrahepatic cholestasis
  2. 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.
  3. PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
  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)
  5. Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
  6. Patients on kidney dialysis
  7. Patient with MELD-score of 40
  8. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
  9. Patient testament excludes the use of life-prolonging measures
  10. Post-operative patients whose liver failure is related to liver surgery
  11. Uncontrolled seizures
  12. Active or uncontrolled bleeding
  13. Weight ≥ 120 kg
  14. Pregnancy
  15. Patient diagnosed with Creutzfeldt-Jakob disease
  16. Participation in another clinical study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01079091

II Medizinische Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Hepa Wash GmbH
Principal Investigator: Wolfgang Huber, PD Dr. II Medizinische Klinik, Klinikum rechts der Isar, Munich
  More Information

Responsible Party: Hepa Wash GmbH
ClinicalTrials.gov Identifier: NCT01079091     History of Changes
Other Study ID Numbers: CS001 
Study First Received: March 1, 2010
Last Updated: December 30, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hepa Wash GmbH:
Liver failure
Hepatic insufficiency
Liver Cirrhosis
Artificial liver
Albumin dialysis

Additional relevant MeSH terms:
Acute-On-Chronic Liver Failure
End Stage Liver Disease
Liver Failure
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases

ClinicalTrials.gov processed this record on May 26, 2016