Trial Information
Current as of April 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The purpose of this Phase 2 clinical trial is to investigate
* the safety of TAK-242 alone or in combination with G-CSF (G-TAK) in patients with sAH and ACLF.
* the effect of TAK-242 alone or in combination with G-CSF (G-TAK) on the disease severity of ACLF.
Study design:
Multi-center, randomized, double-blind, placebo-controlled trial. Study drug will be administered while subjects are hospitalized. Patients will have been hospitalized for their underlying disease.
78 patients to be randomized (1:1:1) to one of the following three arms:
* Standard of care (SOC) plus placebo for TAK-24...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Patients accepted for inclusion into the study must meet all of the following criteria:
- • 1. Male and female subjects ≥18 of age and ≤75 years of age
- • 2. Compliance with acceptable contraceptive methods.
- • 3. With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of \>0.45 and/or in whom steroids are contraindicated.
- • 4. 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.
- Exclusion Criteria:
- * Patients with any of the following criteria are to be excluded:
- • Refusal to give informed consent
- • 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:
- • history of liver transplantation
- • postoperative decompensation after partial hepatectomy
- • 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, sickle cell anemia
- • Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.
- • Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures).
- • Pregnancy or nursing women
- • Allergy to eggs
About Yaqrit Ltd
Yaqrit Ltd. is a pioneering biotechnology company focused on developing innovative therapies to address unmet medical needs in the field of liver disease. With a commitment to advancing healthcare, Yaqrit leverages cutting-edge research and technology to create effective solutions for patients suffering from chronic liver conditions. The company’s clinical trials aim to evaluate novel treatment modalities that enhance liver function and improve patient outcomes, underscoring its dedication to transforming the landscape of liver health through scientific excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported