EUCTR2019-001969-33-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Proof-of-Concept, Phase 2a Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-242 in Subjects With Acute Alcoholic Hepatitis Causing Decompensation of Alcohol related Cirrhosis and Acute-on-Chronic Liver Failure - Phase 2a Study of TAK-242 to Treat Acute-on-Chronic Liver Failure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. In the opinion of the investigator, the subject is deemed capable of understanding and complying with protocol requirements. If the subject is deemed incapable because of encephalopathy, then informed consent can be signed by a representative of the subject, in line with local law and regulation.
- •2. The subject or the subject’s representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •3. The subject is male or female =18 and <75 years of age.
- •4. The subject meets the definition of ACLF Grade 1 or 2 (using the CLIF-C OF score; Appendix G), OR bilirubin criteria (>20 mg/dL at diagnosis); OR criteria of AKI Stage 1b or 2 (Appendix M) after initial supportive treatment with fluids, albumin, or terlipressin; AND the CLIF-C ACLF score is >35 and <64, which is calculated within 16 hours prior to randomization.
- •5. The subject has a history of alcohol-related cirrhosis based on clinical, radiological, and/or histological evidence.
- •6. The subject has continued to drink heavily (defined as >40 gm alcohol/day in women and >60 gm alcohol/day in men) for >6 months with <60 days of abstinence before the onset of jaundice.
- •7. The subject has a history of an acute decompensating event (including, but not limited to, jaundice, ascites, gastrointestinal bleeding, hepatic encephalopathy, and/or acute bacterial infections), occurring within 6 weeks of screening.
- •8. In the judgement of the investigator, the subject does not have a history of previous AH in the past 3 months and present episode is considered a new episode rather than unresolved AH.
- •9. The subject has a clinical and/or liver biopsy diagnosis of alcoholic hepatitis (see definition in Appendix O). A liver biopsy is required for the diagnosis if the subject has potential confounders as defined in the exclusion criteria (see exclusion criteria 4, 5, 9, and 10) and the subject should be excluded if the biopsy suggests an alternative cause for decompensated liver disease.
- •10. The subject has a total white blood cell count =8.0×109/L.
- •11. A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use barrier method of contraception (eg, condom with spermicide)* from signing of informed consent throughout the duration of the study. The male participant agrees to inform female partners of participation in the study and the need for effective contraception*.
- •12. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use an effective method of contraception* from signing of informed consent throughout the duration of the study.
- •*Definitions and effective methods of contraception are defined in Section 9.1.10 and reporting responsibilities are defined in Section 9.1.11.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. The subject has been hospitalized for more than 10 days.
- •2. The subject has received any investigational compound within 30 days prior to the first dose of study drug or is scheduled to receive another investigational drug or device in the course of the study. Concomitant observational studies are allowed.
- •3. The subject has received TAK-242 in a previous clinical study.
- •4. The subject has received corticosteroids for alcohol-induced liver failure within the 4 weeks prior to randomization.
- •5. The subject has cirrhosis from other chronic causes including nonalcoholic steatohepatitis (NASH), hepatitis C virus (HCV), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hemochromatosis, alpha-1-antitrypsin deficiency, or Wilson’s disease.
- •6. The subject has tested positive for SARS-CoV-2 infection within 7 days prior to randomization and administration of study drug.
- •7. The subject has a medical history of co-infection with HIV, hepatitis B virus (HBV), HCV, or hepatitis E virus (HEV). Subjects with a previous diagnosis of hepatitis C treated with a documented course of an approved antiviral therapy for HCV who have achieved a sustained virologic response (defined as an undetectable HCV RNA level 12 weeks after completion of therapy) may be enrolled.
- •8. The subject has proven untreated gram-positive bacterial infection including sepsis, bacterial peritonitis, pneumonia, cellulitis, septic arthritis, osteomyelitis or other gram-positive infection. These subjects can be included once they are culture negative.
- •9. The subject has evidence of untreated infection, including gram negative infection. If a subject has 1 or more underlying infections, he or she may be entered into the study provided that he or she is clinically responding to treatment as judged by clinical and laboratory assessments. Subjects with chronic infections will be excluded.
- •10. The subject has acute or subacute liver failure without underlying cirrhosis.
- •11. The subject has medical history of liver failure due to other causes, including, but not limited, to autoimmune hepatitis, PBC and PSC, drug-induced liver injury, and infections causing liver damage.
- •12. The subject has atypical laboratory screening tests including AST or ALT >400 IU/L, AST:ALT ratio <1.5, and AST <50 or >400 IU/mL unless a liver biopsy has confirmed the diagnosis of AH.
- •13. The subject has a history of liver transplant.
- •14. The subject has developed decompensation at any time in the postoperative period following partial hepatectomy.
- •15. The subject has clinically significant hemolysis or disseminated intravascular coagulation (DIC).
- •16. The subject has chronic and/or pre-existing kidney disease defined as estimated glomerular filtration rate (eGFR) <30 mL/min for 3 months or longer prior to screening.
- •17. The subject has a hemoglobin <8 g/dL and is asymptomatic; subjects may be entered into the study after correction of the anemia by transfusion, with stable hemoglobin and hematocrit for 48 hours.
- •18. The subject has oxygen saturation <90% despite supportive therapy. No subjects who require mechanical ventilation (MV) will be randomized.
- •19. The subject has septic shock (defined as sepsis-induced hypotension [systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg or a SBP decrease >40 mmHg] persisting despite adequate fluid resuscitation). No subjects who require vasopressors to maintain a MAP >70 mmHg will be randomized. Subjects on treatment with terlipres
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