Actively Recruiting
F573 for Injection for the Treatment of Liver Injury/Failure
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2025-11-19
97
Participants Needed
10
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.).
CONDITIONS
Official Title
F573 for Injection for the Treatment of Liver Injury/Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years for the first stage, 18 to 65 years for the second stage, and 18 to 70 years for the third stage
- Diagnosed with liver injury including drug-induced liver injury, chronic hepatitis B infection for more than 6 months, or intrahepatic cholestasis type liver injury
- Serum ALT between 2 to 10 times the upper limit of normal and total bilirubin less than 5 times the upper limit of normal in the first stage
- For DILI patients, liver biochemical abnormalities must not exceed 90 days in duration
- For second stage, DILI patients must have ALT greater than 3 times ULN and TBil greater than 2 times ULN, with abnormalities persisting no more than 60 days
- For intrahepatic cholestasis type liver injury, TBil greater than 2 times ULN, ALP greater than 1.5 times ULN, and ALT greater than 1 times ULN
- For third stage, patients with chronic and acute liver failure with TBil greater than or equal to 5 times ULN, may have grade 1-2 hepatic encephalopathy or ascites, and AARC score 5 to 10
- Willingness of participant and partner 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 in the first stage or advanced liver cirrhosis or liver cancer in the second stage
- Liver stiffness measurement at screening 12.4 kPa or higher in first stage, or 18.0 kPa or higher in second stage
- Severe or life-threatening diseases of heart, lung, brain, kidney, gastrointestinal system, or cancer
- Abnormal laboratory values including low platelets or hemoglobin, prolonged prothrombin time, or left ventricular ejection fraction below 50%
- Allergy or intolerance to the investigational drug
- Inability to express main complaints due to mental illness or severe neurosis
- Poor compliance or lack of partner support
- Pregnant, breastfeeding, or trying to conceive women
- Participation in other clinical trials within 3 months
- Use of liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization
- Use of glucocorticoids or interferon drugs within 3 days before randomization (second stage only)
- Severe ascites or hepatic encephalopathy grade 3 or higher (third stage)
- Liver transplantation completed or planned within 1 month (third stage)
- Artificial liver treatment within 1 week before screening (third stage)
- Severe infections uncontrolled by drugs or severe underlying diseases (third stage)
- Severe varicose veins with bleeding risk detected by endoscopy or imaging within 1 month before screening (third stage)
- Acute kidney injury defined by serum creatinine increase or decreased urine volume (third stage)
AI-Screening
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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
CONTACT
J
junqi niu, Dr
CONTACT
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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