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New treatment option for Acute Liver Failure
Official title F573 for Injection for the Treatment of Liver Injury/Failure
ClinicalTrials.gov ID: NCT05689645
What this study is testing
What is F573 for injection?
F573 for injection is an investigational medicine, given as an once-daily injection into a muscle, being studied as a potential treatment for acute liver failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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...
- 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]...
You likely can't join if
- The first stage: people meeting one of the following conditions will not be included in the trial:
- According to the investigator's judgment, the people 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;
See the full eligibility criteria
Who can join
- （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...
- 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...
- 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...
- 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...
- 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 people (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 people are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required...
What rules you out
- The first stage: people meeting one of the following conditions will not be included in the trial:
- According to the investigator's judgment, the people 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 \ 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: people 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;
- 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 and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;
- Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;
- The researcher considers any circumstances unsuitable for inclusion. The third stage: people meeting one of the following conditions will not be included in the trial:
- Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;
- Severe grade 3 ascites or stubborn ascites;
- Patients with ≥ grade 3 hepatic encephalopathy;
- Patients who received artificial liver treatment within 1 week before screening;
- 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...
- 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;
- Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:
- Serum creatinine (Scr) increased ≥26.5 μmol/L (0.3 mg/dL, 1 mg/dL=88.4 μmol/L) within 48 h;
- The Scr increase exceeds 1.5 times or more of the base value within 7 days;
- Decreased urine volume (\<0.5 mL/kg/h) for more than 6 hours;
- 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; 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Qingyuan, Guangdong, China
- Shiyan, Hubei, China
- Huaihua, Hunan, China
- Pingxiang, Jiangxi P, China
- Changchun, Jilin, China
- Binzhou, Shandong, China
- Heze, Shandong, China
- Taiyuan, Shanxi, China
- Luzhou, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Qingyuan, Guangdong, China; Shiyan, Hubei, China; Huaihua, Hunan, China; Pingxiang, Jiangxi P, China; Changchun, Jilin, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.