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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Rajiv
Jalan
+44 (0)2074332795
rajiv.jalan@efclif.com
Dr
Cornelius
Engelmann
+49 (0)30 450530008
cornelius.engelmann@charite.de
Prof
Rajiv
Jalan
+44 (0)2074332795
rajiv.jalan@efclif.com
Severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This clinical research study is a medical study that helps answer important questions about how safe the investigational medications are and whether and how well they work. The investigational medication, TAK-242, is aimed at stopping an “over-reaction” of the immune system (the body’s defence system) whilst G-CSF encourages the liver cells to grow. In patients with severe alcoholic hepatitis (sAH) and acute-on-chronic liver failure (ACLF), this over-reaction may cause the liver and other organs in the body to suddenly stop working (organ failure). It is hoped that by blocking this over-reaction and encouraging patients' liver cells to grow their condition may improve. The aim of this study is to learn more about whether the investigational medications, (TAK-242 and G-CSF) work and how safe they are compared with a placebo in people with severe alcohol-related liver disease.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Refusal to give informed consent 2. 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 >0.5 ug/kg/min to maintain mean arterial pressure >70 mmHg 3. Subject has received any investigational drug within 30 days of randomization4. Subject has any of the following conditions: 4.1. History of liver transplantation 4.2. Postoperative decompensation after partial hepatectomy 4.3. Liver failure without evidence of underlying chronic liver disease5. Any untreated infections (<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV6. 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 safety7. Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anaemia 8. Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency9. Active malignancy, premalignant haematological disorders (e.g. myelodysplastic syndrome, chronic myeloid leukaemia) or multiorgan failure (≥4 organ failures)10. Pregnancy or nursing women
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Rajiv
Jalan
+44 (0)2074332795
rajiv.jalan@efclif.com
Dr
Cornelius
Engelmann
+49 (0)30 450530008
cornelius.engelmann@charite.de
Prof
Rajiv
Jalan
+44 (0)2074332795
rajiv.jalan@efclif.com
The study is sponsored by Yaqrit Ltd and funded by Horizon 2020.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
