Acute Liver Failure Subgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77 MedDRA version: 9.1 Level: LLT Classification code 10049844 Term: Acute liver failure
Conditions
Interventions
Product Name: Human heterologous liver cells (for infusion)
Product Code: HHLivC
Pharmaceutical Form: Intravenous infusion
Sponsors
Cytonet GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 years and above • Written informed consent before enrolment • Patient suffering from ALF manifested as - Hepatic encephalopathy grade ? I (grade = III for patients with ALF due to acetaminophen poisoning) - INR = 2.3* OR INR = 1.5 together with MELD Score = 25* - GOT, GPT and GLDH increased by at least 3 times UNL in absence of signs of chronic liver disease ( = no fibrosis or cirrhosis) • Patient not eligible for orthotopic liver transplantation • Onset of first symptom(s) of liver failure less than 12 weeks ago • No anticoagulative therapy within the last 72 hours before the two consecutive measurements mentioned (*) • No clinically significant brain oedema • No manifest sepsis • No haemodynamic instability • No massive bleeding • No multiorgan failure (lung, kidney, heart affected) *determined in two consecutive measurements after a 8-12 hours time span (14 hours must not be exceeded) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute liver insufficiency in presence of symptomatic chronic liver disease (fibrosis or cirrhosis of the liver) • Acute liver failure in case of transplant primary non-function • Acute liver failure due to Budd-Chiari-Syndrome or veno-occlusive disease • Thrombosis of portal vein or persisting impairment of anterograde portal blood flow • Allergic disposition for antibiotics used during manufacturing of liver cell transplants • Encephalopathy other than hepatic • Massive ascites (> 3 l) • Malignancies (except basaliomes) except there is • no evidence of disease within the last 2 years • or all of the following: - stable condition after tumor therapy (i.e. tumor in remission and life expectancy is > 6 months) - liver failure is not due to malignant disease and/or to therapy thereof - no manifestation of malignant disease within the liver (to be excluded by CT) • Clinically manifest acquired immunodeficiency syndrome (AIDS) • Allergy to contrast medium • Contraindication to immunosuppressive therapy (e.g. severe acute bacterial, viral or fungal infection, intolerability to immune suppression) • Treatment with extracorporeal liver assist devices (e.g. MARS, Prometheus, HepatAssist) • Pregnancy or lactation • Participation in another clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to investigate the efficacy and safety of multiple applications of liver cell suspension in patients with ALF. The primary variable is the survival rate at 8 weeks after randomization.;Secondary Objective: Efficacy: • Survival rate at 6 months after randomization • Hepatic encephalopathy score • Karnofsky -Index at week 2, 4 and 8 • Laboratory parameters I: INR, AFP, albumin, bilirubin, liver enzymes (GOT, GPT, GLDH, GGT, AP) • Laboratory parameter IA: Factor V • Pharmacoeconomic evaluation (duration of initial hospitalization, number and duration of hospitalizations after initial admission, total days at ICU, concomitant medical interventions including blood substitution therapy) • Assessment of Quality of Life (QoL) Safety: • All adverse events and serious adverse events • Infection events • Laboratory parameter IB: blood levels of immunosuppression • Laboratory parameters II: CRP, lactate, creatinine, haematology (haemoglobin, hematocrit, erythrocytes, leucocytes including differential count, platelets) • Vital signs;Primary end point(s): Survival rate at 8 weeks after randomization | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed