💬In plain words
What the trial is, and whether it could suit you
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .
The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
(1)The first stage:
Participants who meet all of the following criteria will be enrolled in the study:
1. Age ≥18 and ≤60 years old, gender is not limited;
2. Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the "Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)"). Screening patients with CHB may provide etiological (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.
3. Serum ALT: 2\~ 10× upper limit of normal (ULN), TBil: \<5×ULN;
4. DILI patients: the abnormal duration of liver biochemical indexes \[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\] does not exceed 90 days;
5. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;
6. Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.
(2)The second stage:
Subjects meeting all of the following criteria will be included in the study:
1. Age ≥ 18 and ≤ 65 years old, with no gender restrictions;
2. According to the "Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;
1. Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \> 3 times the upper limit of normal (ULN), and TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;
2. Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L); ② ALP \> 1.5 times the ULN; ③ALT\>1×ULN;
3. The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;
4. They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.
The third stage:
Subjects who meet all of the following criteria will be enrolled in the study:
1\. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the "Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)" may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.
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Exclusion Criteria:
The first stage:
Subjects meeting one of the following conditions will not be included in the trial:
1. According to the investigator's judgment, the subjects were patients with cholestatic liver injury;
2. Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
3. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;
4. There are the following laboratory test values or abnormal test values:
1. Blood routine: platelet (PLT) \<75× 109/L, hemoglobin (HGB) \<90 g/L;
2. Prothrombin activity \<40%, prothrombin time (PT) extended \>5 s;
3. Left ventricular ejection fraction (LVEF) \<50%;
5. Allergic or intolerant to the investigational drug, or allergic;
6. The subject is unable to express his main complaint, such as mental illness and severe neurosis;
7. Poor compliance can not partner;
8. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
9. Participants in other clinical trials within 3 months;
10. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;
11. The researcher considers any circumstances unsuitable for inclusion.
The second stage:
Subjects meeting one of the following conditions will not be included in the trial:
1. The diagnosis is advanced liver cirrhosis (with complications such as ascites and hepatic encephalopathy), or liver cancer, or when liver stiffness measurement (LSM) is ≥ 18.0 kPa during screening.
2. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;
3. There are the following laboratory test values or abnormal test values:
1. Blood routine: platelet (PLT) \<100×109/L, hemoglobin (HGB) \<100 g/L;
2. INR\>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;
3. Left ventricular ejection fraction (LVEF) \<50%;
4. Allergic or intolerant to the investigational drug, or allergic;
5. The subject is unable to express his main complaint, such as mental illness and severe neurosis;
6. Poor compliance can not partner;
7. Pregnant women, breastfeeding w