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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
F573 for injection
DrugThe first stage:the first 16 patients with liver injury were given doses of 0.5, 1.0 and 2.0 mg/kg, and the subsequent 9 patients with CHB were given doses of 2.0 mg/kg, with an administration volume of 2 mL and intramuscular injection (IM) according to the efficacy and safety test results of the first 16 patients. The dose was given once a day for 7 days and calculated according to the weight of the last visit. The second stage:According to the results of Phase I efficacy and safety trials, the dosage was determined to be 0.5 mg/kg and 2.0 mg/kg, the dosage volume was 2 mL, intramuscular injection (IM), once a day for 14 days, and the dosage was calculated according to the weight of the latest visit. The third stage:The dosage was determined according to the results of the first and second phase efficacy and safety trials. The dosage volume was 2 mL, intramuscular injection (IM), once a day for 28 consecutive days, and the dosage was calculated according to the weight of the latest .
Sterilizing water for injection
DrugThe composition of this product is water for injection, and the dosage volume is 2mL for intramuscular injection. Medication course: The first stages were administered once a day for 7 days and second stages were administered once a day for 14 days. The third stage was administered once a day for 28 days.
Treatment groups
97 Participants
are divided into 2 treatment groupsGroup A: F573 for injection groupsExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AE), serious adverse events (SAE)
to record Adverse events and serious adverse events in the trial
Time frame
7 days of administration in the first stage and 14 days of administration in the second stage2
Adverse events (AE), serious adverse events (SAE)
to record Adverse events and serious adverse events in the trial
Time frame
followed up for 28 days in the first stage and followed up for 14 days in the second stage3
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Time frame
7 days of administration in the first stage and 14 days of administration in the second stage4
clinical laboratory tests ：blood routine
blood routine report contains the following values: RBC,WBC,NE%,LY%,HGB,PLT.
Time frame
followed up for 28 days in the first stage and followed up for 14 days in the second stageSecondary outcomes
1
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Time frame
after 7 days of administration in the first and second stages2
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Time frame
after 14 days of administration in the second stages3
Basin alanine aminotransferase (ALT)
ALT values reflect hepatocyte injury
Time frame
followed up for 28 days in the first stage and followed up for 14 days in the second stage4
peak concentration (Cmax)
Pharmacokinetic parameters: peak concentration (Cmax).
Time frame
12 hours after administration in the first and second stagesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov