Hepatitis B-related liver fibrosis, non-alcoholic liver fibrosis, and immune-mediated liver fibrosis (such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, etc.)
Conditions
Interventions
group B:CREPT-618 3.0mg/kg
group A:CREPT-618 2.5mg/kg
Sponsors
Chengdu Fifth People’s hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Capable of understanding and following the protocol requirements, voluntarily participating in the study, and providing signed written informed consent (ICF). 2.Male or female adult participants between 18 and 70 years of age (inclusive), based on the date of informed consent. 3.At screening, male participants weigh =50 kg, female participants weigh =45 kg, and have a body mass index (BMI, calculated as weight [kg]/height² [m²]) between 18.0 and 30.0 kg/m², inclusive of the boundaries. 4.Liver fibrosis due to hepatitis B, non-alcoholic liver fibrosis, or immune-mediated liver fibrosis (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis); and, within 6 months prior to screening, a histopathological diagnosis of chronic liver fibrosis stage F1–F4 (if applicable) or a magnetic resonance elastography (MRE) result = 3.0 kPa. 5.Liver function as assessed by Child-Pugh score is 5–6 points (Class A). 6.Male participants (and their partners) or female participants must agree to use one or more effective methods of contraception from the time of signing the ICF until at least 90 days after the last dose, and must have no plans for pregnancy, sperm donation, or egg donation for at least 90 days after the last dose.
Exclusion criteria
Exclusion criteria: 1.Imaging evidence of a malignant liver mass or alpha-fetoprotein (AFP) > 50 ng/mL at screening. 2.Participants with a clinically significant history of drug allergy or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a known or suspected allergy (as determined by the investigator) to the investigational product (including angiotensin receptor neprilysin inhibitors, angiotensin receptor blockers, and renin inhibitors) or any of its excipients. 3.Participants with decompensated cirrhosis, defined by the presence of complications such as ascites, hepatic encephalopathy, or esophageal/gastric variceal hemorrhage. 4.Any of the following: acute liver injury of any etiology, hepatorenal syndrome, severe ascites or pleural effusion requiring paracentesis/drainage, severe portal hypertension or prior portosystemic shunt surgery, or hemoglobin level 2 weeks within 6 months prior to the first dose. 13.Participants who have received continuous and regular anti-fibrotic medication (including but not limited to: Fufang Biejia Ruangan Tablets/Capsules, Fuzheng Huayu Tablets/Capsules, Anluo Huaxian Pills) within 3 months prior to the first dose. 14.At screening or prior to randomization, participants who meet any of the following laboratory criteria: a) Serum alanine aminotransferase (ALT) =5× upper limit of normal (ULN); alkaline phosphatase (ALP) =2×ULN; or ALT =3×ULN with concomitant total bilirubin (TBil) =2×ULN. b) Platelet (PLT) count 1.5; or any other contraindications to liver histo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AE) and serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fibrosis improvement rate; | — |
Countries
China
Contacts
Public ContactXu Xiaomei
Chengdu Fifth People’s hospital
Outcome results
None listed