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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).
EU CTIS ID: 2022-501026-37-00
What this study is testing
The primary objective of this Phase 2 clinical trial is to investigate the safety of TAK-242 in combination with G-CSF (G-TAK) in patients with sAH and ACLF.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.