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 groups

Locations

10
Beijing You 'an Hospital, Capital Medical University BeijingBeijing Municipality, China
Qingyuan People's Hospital (Sixth Affiliated Hospital of Guangzhou Medical University) QingyuanGuangdong, China
Shiyan City Taihe Hospital ShiyanHubei, China
Hunan Medical College General Hospital (formerly Huaihua City First People's Hospital) HuaihuaHunan, China

Sponsors and collaborators

Beijing Continent Pharmaceutical Co, Ltd.

Lead sponsor