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F573 for Injection for the Treatment of Liver Injury/Failure Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Trial
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2025-11-19
97
Participants Needed
10
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety of F573 for injection in patients with various types of liver injury, including drug-induced liver injury (DILI), chronic hepatitis B (CHB), and intrahepatic cholestatic liver injury. This Phase II randomized, double-blind, placebo-controlled clinical trial aims to understand how F573 affects patients at risk of liver failure due to these injuries. The study is conducted in multiple stages. In the first stage, 25 patients receive different doses of F573 or a placebo via intramuscular injection once daily for 7 days. The second stage enrolls 24 patients treated with F573 or placebo at two dose levels once daily for 14 days. The third stage involves a 28-day treatment period with daily intramuscular injections of F573 or placebo, alongside acetylcysteine injection as basic treatment. Dosages are adjusted based on patient weight and earlier trial results. Participants undergo a screening period of 14 days before treatment and a follow-up period of 90 days after treatment completion. Throughout the study, patients receive various assessments including laboratory blood and urine tests, vital sign monitoring, physical exams, electrocardiograms, liver ultrasounds, and biomarker evaluations. Researchers monitor for adverse events, liver function scores, survival status, and medication use to evaluate safety and effects of the treatment.
CONDITIONS
Brief Title
F573 for Injection for the Treatment of Liver Injury/Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years (first stage) or 18 to 65 years (second stage), no gender restrictions
- Diagnosed with liver injury including hepatocyte injury, mixed liver injury, chronic hepatitis B infection over 6 months, drug-induced liver injury, or intrahepatic cholestasis liver injury
- Specific liver enzyme and bilirubin levels within defined ranges depending on stage
- Duration of abnormal liver biochemical indexes does not exceed 90 days (first stage) or 60 days (second stage)
- Willingness to use effective contraception from screening until 6 months after last drug administration
- Signed informed consent and ability to comply with study requirements
You will not qualify if you...
- Diagnosed with cholestatic liver injury (first stage) or advanced liver cirrhosis, liver cancer, or liver stiffness above 18.0 kPa (second stage)
- Severe or life-threatening heart, lung, brain, kidney, gastrointestinal, systemic diseases, or malignant tumors
- Abnormal laboratory values such as low platelets or hemoglobin, prolonged prothrombin time, or low left ventricular ejection fraction
- Allergy or intolerance to the investigational drug
- Mental illness or inability to express main complaints
- Poor compliance
- Pregnant, breastfeeding, or women trying to conceive
- Participation in other clinical trials within the last 3 months
- Use of liver protection drugs or certain other medications within 3 days before randomization
- Patients who had liver transplantation or plan transplant within 1 month (third stage)
- Severe ascites or hepatic encephalopathy grade 3 or higher (third stage)
- Recent artificial liver treatment or severe infections uncontrolled by drugs (third stage)
- Severe bleeding risks or acute kidney injury (third stage)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive the experimental drug or placebo by intramuscular injection once a day for 7 days at doses of 0.5, 1.0, or 2.0 mg/kg depending on their group. Pharmacokinetic blood samples may be collected for some participants.
Daily visits for 7 days (in-person)
Duration - 14 days
Participants receive the experimental drug or placebo by intramuscular injection once a day for 14 days at doses of 0.5 mg/kg or 2.0 mg/kg depending on their group.
Daily visits for 14 days (in-person)
Duration - 28 days
Eligible participants receive the experimental drug or placebo by intramuscular injection once a day for 28 consecutive days. Participants also receive acetylcysteine injection as basic treatment during this stage.
Daily visits for 28 days (in-person)
Duration - 90 days
Participants are followed for safety assessments and monitoring of outcomes for 90 days after the end of treatment.
Visits at planned intervals during follow-up (in-person)
Trial Site Locations
Total: 10 locations
1
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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2
Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University)
Qingyuan, Guangdong, China
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3
Shiyan City Taihe Hospital
Shiyan, Hubei, China
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4
Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital)
Huaihua, Hunan, China
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5
Pingxiang Second People's Hospital
Pingxiang, Jiangxi P, China
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6
First Hospital of Jilin University
Changchun, Jilin, China
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7
The Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, China
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8
Heze Municipal Hospital
Heze, Shandong, China
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9
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
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10
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
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Research Team
L
ling zhang, Dr
J
junqi niu, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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