Primary Biliary Cholangitis
Conditions
Interventions
Positive control group:Ursodeoxycholic acid capsules were orally administered daily for 84 consecutive days.
Test group 1:Subcutaneous injection of crept-618 once
Test group 2~5:Crept-618 was injected subcutaneously for 4 times
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 65, regardless of gender; 2. Participants who meet the diagnostic criteria for primary biliary cholangitis (PBC), defined as having at least 2 of the following 3 criteria: (1) indicators reflecting cholestasis such as elevated ALP (see inclusion criteria 3); (2) positive AMA or AMA-M2, or if AMA is negative, positive anti-gp210 or anti-Sp100 antibodies; (3) liver biopsy within 6 months prior to screening consistent with PBC; 3. Participants at screening with 1.67×ULN ULN; 4. The experimental drug group meets at least 1 of the following 3 criteria: (1) treatment-naive participants who have not used UDCA; (2) participants unable to tolerate UDCA (have not used UDCA for >= 3 months at the time of signing the informed consent); (3) participants with poor response to UDCA (used UDCA for at least 6 months at the time of signing the informed consent with stable dosage (not less than 13-15 mg/kg/d) for >= 3 months); 5. The control group at the time of signing informed consent includes PBC biochemical responders to UDCA for >= 6 months with stable dosage (not less than 13-15 mg/kg/d) for >= 3 months; 6. Individuals must be able to comply with the instructions for the management of research medication and be able to complete the research assessment plan; 7. Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The researcher believes that diseases that may confuse the research results (such as tumors) or that the participant is not suitable to participate in this study (such as severe physical or mental illness or abnormal laboratory tests); 2. Severe comorbidities or abnormal test results: ALT or AST >= 5×ULN; total bilirubin (Tbil) >= 2×ULN; platelet (PLT) 1.3; serum creatinine (Cr) >= 1.5×ULN or serum creatinine clearance = 450 ms in males and >= 470 MS in females at screening (fridericia formula); Or it is expected that QT interval prolonging drugs will be used during the trial; 8.There are diseases or physiological conditions that interfere with the absorption, distribution, metabolism or excretion of test drugs, such as those who have previously undergone gastric bypass; 9.Those who have a history of malignant tumor within 5 years before signing the informed consent (excluding cured skin basal cell carcinoma, carcinoma in situ and papillary thyroid carcinoma); 10.Those who used medium or strong inhibitors or inducers of CYP3A4 enzyme 14 days before signing the informed consent and during the whole trial (strong inducers mainly include rifampicin, carbamazepine, phenytoin, phenobarbital, etc.; medium strength inducers mainly include bosentan, dexamethasone, rifapentine, etc.; strong inhibitors mainly include ketoconazole, itraconazole, posaconazole, voriconazole, indinavir, clarithromycin, etc.; medium strength inhibitors mainly include fluconazole, verapamil, diltiazem, erythromycin, Schisandra, dronedarone, cyclosporine, amiodarone, cimetidine Ding, imatinib, etc.); 11.Patients with diseases that may cause non hepatic ALP elevation (such as paget's disease) or diseases that may lead to life expectancy less than 2 years; 12.Those who have a history of malignant tumor within 5 years before signing the informed consent (excluding cured skin basal cell carcinoma, carcinoma in situ and papillary thyroid carcinoma); 13.The following drugs were used from 28 days before signing the informed consent to the entire clinical study period: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; Fenofibrate or other fibrates; Budesonide and other systemic corticosteroids; Hepatotoxic drugs (including a - methyldopa, sodium valproate, isoniazid, nitrofurantoin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALP changes from baseline during multiple administrations;Frequency and severity of adverse events;Changes from baseline in the subjects' Itch numerical rating scale (NRS and 5D itch scale, 5D itch) during multiple administrations; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity;Single dose pharmacokinetics;Multiple dosing pharmacokinetics;Preliminary validity; | — |
Countries
China
Contacts
Public ContactGang Mai
Deyang People's Hospital
Outcome results
None listed