F573 for Injection for the Treatment of Liver Injury/Failure

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Liver Failure, Acute-On-Chronic Liver Failure

In brief

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.).

Key facts

Study ID

NCT05689645

Run by

Beijing Continent Pharmaceutical Co, Ltd.

People needed

97

Starts

2023-03-24

Expected to finish

2026-09-01

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• （1）The first stage:
• Participants who meet all of the following criteria will be enrolled in the study:
• Age ≥18 and ≤60 years old, gender is not limited;
• 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.
• Serum ALT: 2\~ 10× upper limit of normal (ULN), TBil: <5×ULN;
• DILI patients: the abnormal duration of liver biochemical indexes [ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time] does not exceed 90 days;
• The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;
• 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:
• Age ≥ 18 and ≤ 65 years old, with no gender restrictions;
• 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;
• 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;
• 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;
• 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;
• 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:
• 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.

You may not qualify if…

• The first stage:
• Subjects meeting one of the following conditions will not be included in the trial:
• According to the investigator's judgment, the subjects were patients with cholestatic liver injury;
• Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
• Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;
• There are the following laboratory test values or abnormal test values:
• Blood routine: platelet (PLT) <75× 109/L, hemoglobin (HGB) <90 g/L;
• Prothrombin activity <40%, prothrombin time (PT) extended >5 s;
• Left ventricular ejection fraction (LVEF) <50%;
• Allergic or intolerant to the investigational drug, or allergic;
• The subject is unable to express his main complaint, such as mental illness and severe neurosis;
• Poor compliance can not partner;
• Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
• Participants in other clinical trials within 3 months;
• Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;
• 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:
• 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.
• Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;
• There are the following laboratory test values or abnormal test values:
• Blood routine: platelet (PLT) <100×109/L, hemoglobin (HGB) <100 g/L;
• INR>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;
• Left ventricular ejection fraction (LVEF) <50%;
• Allergic or intolerant to the investigational drug, or allergic;

Where it is running

• Beijing You 'an Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University) — Qingyuan, Guangdong, China (enrolling)
• Shiyan City Taihe Hospital — Shiyan, Hubei, China (enrolling)
• Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital) — Huaihua, Hunan, China (enrolling)
• Pingxiang Second People's Hospital — Pingxiang, Jiangxi P, China (enrolling)
• First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• The Affiliated Hospital of Binzhou Medical University — Binzhou, Shandong, China (enrolling)
• Heze Municipal Hospital — Heze, Shandong, China (enrolling)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (enrolling)
• Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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