F573 for Injection for the Treatment of Liver Injury/Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Continent Pharmaceutical Co, Ltd.
About this trial
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.).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Blood routine: platelet (PLT) <75× 109/L, hemoglobin (HGB) <90 g/L;
Trial design
Treatments tested in this trial
- F573 for injection
- Sterilizing water for injection
Treatment groups
97 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov