F573 for Injection for the Treatment of Liver Injury/failure

Launched by BEIJING CONTINENT PHARMACEUTICAL CO, LTD. · Jan 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called F573, which is being tested for its safety in treating people with liver injuries, including those caused by medications or chronic hepatitis B virus infection. The trial is currently looking for participants aged 18 to 70 who have specific liver conditions, such as elevated liver enzymes or diagnosed liver injury, and who have been infected with hepatitis B for longer than six months. Participants will be randomly assigned to receive either the F573 injection or a placebo (a substance with no active medication) to compare the effects.

If you or someone you know is considering joining this study, they should be aware that they will need to follow certain guidelines, such as agreeing to use effective contraception and signing an informed consent form. Throughout the trial, participants will be closely monitored to ensure their safety. It's important to note that individuals with severe other health issues, such as serious heart or lung diseases, or those who have recently undergone specific treatments, may not be eligible to participate. This trial aims to provide valuable information about the potential benefits and safety of F573 for people suffering from liver injuries.

Gender

ALL

Eligibility criteria

• 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 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 clinically diagnosed with drug-induced liver injury or intrahepatic cholestatic liver injury according to the Chinese Guidelines for Diagnosis and Treatment of drug-induced Liver Injury (2023 edition);
• • 3. Serum ALT of subjects: 5\~20× upper limit of normal (ULN), TBil: 1\~5×ULN (ULN of TBil according to the international standard value of 17.1μmol /L);
• • 4. DILI patients: Abnormal duration of liver biochemical indexes (ALT, AST, ALP, TBil) is notMore than 60 days;
• • 5. Patients with intrahepatic cholestasis liver injury: ALP≥1.5×ULN and ≤10×ULN;
• • 6. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration;
• • 7. 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.
• 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.
• • -
• 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. Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;
• • 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 women or women of childbearing age who are trying to conceive;
• • 8. Participants in other clinical trials within 3 months;
• • 9. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;
• • 10. Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;
• • 11. The researcher considers any circumstances unsuitable for inclusion.
• The third stage:
• Subjects meeting one of the following conditions will not be included in the trial:
• • 1. Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;
• • 2. Severe grade 3 ascites or stubborn ascites;
• • 3. Patients with ≥ grade 3 hepatic encephalopathy;
• • 4. Patients who received artificial liver treatment within 1 week before screening;
• • 5. Patients with severe underlying diseases, such as respiratory system, digestive system, circulatory system, endocrine and other diseases and malignant tumors, and patients with severe infections that cannot be controlled by drugs;
• • 6. During the screening period or within 1 month before screening, the results of gastroscopy or imaging (abdominal B-ultrasound, CT or MRI) examination suggest severe varicose veins with bleeding risk;
• 7. Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:
• • 1. Serum creatinine (Scr) increased ≥26.5 μmol/L (0.3 mg/dL, 1 mg/dL=88.4 μmol/L) within 48 h;
• • 2. The Scr increase exceeds 1.5 times or more of the base value within 7 days;
• • 3. Decreased urine volume (\<0.5 mL/kg/h) for more than 6 hours;
• • 8. Allergic or intolerant to the investigational drug, or allergic;
• • 9. The subject is unable to express his main complaint, such as mental illness and severe neurosis;
• • 10. Poor compliance can not partner; 11 Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;
• • 12. Participants in other clinical trials within 3 months; 13. The researcher considers any circumstances unsuitable for inclusion.