Phase2, double-blind, randomized, placebo-controlled, multicentre study to evaluation the safety, efficacy, and pharmacokinetics of TAK-242 and Granulocyte Colony-Stimulating Factor (G-CSF) (G-TAK) in subjects with severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF).

Phase 1

• Registration Number: CTIS2022-501026-37-00
• Lead Sponsor: Alpha Bioresearch S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Male and female subjects =18 of age and =75 years of age, Compliance with acceptable contraceptive methods., With a diagnosis of severe alcoholic hepatitis (APPENDIX 12) that is resistant to steroid therapy as defined by a Lille score of >0.45 (APPENDIX 9) and/or in whom steroids are contraindicated., Eligible subjects will have Grade 1- 3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of >35 and <60. APPENDIX 2

Exclusion Criteria

Refusal to give informed consent, Pregnancy or nursing women, Mechanical ventilation due to respiratory failure and/or need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of >0.5ug/kg/min to maintain mean arterial pressure > 70mmHg, Subject has received any investigational drug within 30 days of randomization, Subject has any of the following conditions: o history of liver transplantation o postoperative decompensation after partial hepatectomy o liver failure without underlying chronic liver injury, Any untreated infections (<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV., Chronic or pre-existing kidney failure, survival prognosis of <6 months due to severe co-morbid conditions that might confound study results or compromise subject safety, Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding (according to BAVENO V; APPENDIX 16), sickle cell anaemia, Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency., Active malignancy, premalignant haematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukaemia) or multiorgan failure (= 4 organ failures).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified