Acute liver failure MedDRA version: 14.1 Level: LLT Classification code 10049844 Term: Acute liver failure System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: ALF-5755
Product Code: ALF-5755
Pharmaceutical Form: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
Alfact Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must meet all inclusion criteria prior to randomization: 1.A signed written informed consent from patient or from patient's next of kin 2.Early stage acute liver failure OR severe acute hepatitis defined as: -15% = PR =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for randomization: 1.Acetaminophen-induced hepatitis defined as acetaminophen intake > 4 g/day, at least once in the 7 days prior to baseline 2.Shock liver (ischemic hepatopathy) OR HELLP syndrome OR Budd-Chiari syndrome OR intrahepatic malignancy 3.Serum creatinine = 180 µmol/L 4.Body Mass Index (BMI) = 35 5. Septic shock requiring administration of inotropic drugs 6.Uncontrolled active bleeding 7.Patients who received fresh frozen plasma, PPSB (Prothrombine-Proconvertine-Stuart-B), or vitamin K infusion over the last 24 hours 8.Patient receiving liver support device treatment, including but not exclusively bioartificial liver (BAL), Extracorporeal Liver Assist Device (ELAD), transgenic pig perfusion 9.Patient receiving hemodialysis, hemofiltration or hemodiafiltration treatment 10.Intractable arterial hypotension (arterial systolic blood pressure equal to or below 70 mmHg) present or require inotropic drugs at baseline 11.Human Immunodeficiency Virus (HIV) positive patient 12.Active cancer 13.Pregnancy or breast-feeding 14.Surgery within 4 weeks prior to baseline, or unsolved surgical disease outside liver transplantation. 15.Patient included in another clinical trial within 4 weeks prior to baseline 16.Patient with organ or bone-marrow allograft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ALF-5755 versus placebo, measured by rate of change of prothrombin ratio (PR) during the 72 hours following treatment initiation, in patients with nonacetaminophen SAH and early stage ALF.;Secondary Objective: - To evaluate the safety and tolerability of ALF-5755 versus placebo in patients with nonacetaminophen SAH and early stage ALF. - To determine the pharmacokinetic (PK) parameters of ALF-5755 versus placebo in patients with nonacetaminophen SAH and early stage ALF.;Primary end point(s): Rate of change of PR during 72 hours following treatment initiation | — |
Countries
Germany
Outcome results
None listed