A Phase II Study of ADR-001 in Patients with Compensated Liver Cirrhosis

Terai Shuji0 个研究点目标入组 9 人开始时间: 2021年11月12日最近更新: 2023年10月17日

适应症

试验速览

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•1) Men and Women >= 20 years old of age on the date of consent.
•2) Patient with cirrhosis any of the following criteria.
•F4 cirrhotic patients diagnosed by previous liver biopsy.
•F4 cirrhotic patients diagnosed by MR elastography.
•F4 cirrhotic patients diagnosed by ultrasound elastography.
•3) Patients with cirrhosis any of the following criteria.
•Alcoholic steatohepatitis, abstaining from alcohol for more than 6 months.
•Non-alcoholic steatohepatitis, on exercise and diet therapy for more than 6 month.
•Chronic hepatitis B, with negative for HBV-DNA for at least 6 months after a treatment with nucleic acid analogues.
•Past Chronic hepatitis C, attained a sustained virological response by antiviral therapy for more than 12 months.
•4) Child-Pugh score: 6 points or less.
•5) Patients capable of giving written informed consent.

•1) Malignancy (except relapse-free survival >5 years).
•2) Gastroesophageal varices to treat.
•3) History of venous thrombosis or pulmonary embolism.
•4) A neutrophil count below the lower limit of the reference.
•5) D-dimer level >=3.0 microgram/mL or FDP level >= 15 microgram/mL
•6) Serum creatinine level >= 2.0 mg/dL
•7) Serum total-bilirubin level >= 5.0 mg/dL
•8) Patients experienced transplantation or cell therapy, previously.
•9) Pregnancy, lactation, or desire to have children in study period.
•10) Severe cardiovascular, renal, or respiratory disease.
•11) Alcoholic liver cirrhosis patients with The Alcohol Use Disorders Identification Test (AUDIT) >=8 points.
•12) Inadequate physical condition, as diagnosed by their physician.

发起方

Terai Shuji