Primary Biliary Cholangitis (PBC) Clinical Trial
Official title:
A Phase II Study to Evaluate Safety, Tolerability and Efficacy, of CS0159 in Patients Subjects With PBC (Primary Biliary Cholangitis), Multicenter, Randomized 12-week, Double-blind, Placebo-controlled, and 40-weeks Open Study
A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).
Status | Recruiting |
Enrollment | 75 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. When signing ICF age=18 years=75 years, male or female 2. Meets the diagnostic criteria of PBC, such as elevation ALP, positive AMA or AMA-M2, If negative for AMA, positive for PBC specific antibody and Liver biopsy meeting PBC criteria six months before screening 3. 1.67 × ULN =ALP = 10 × ULN and TBil= 3 × ULN 4. UDCA=6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) =3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for =3 months before randomization) 5. Understand the study content, comply with the study protocol, and sign the ICF voluntarily - Exclusion Criteria: 1. ALT or AST>5×ULN; 2. OCA(Obercholic acid) in the 3 months prior to randomization 3. Known concomitant hepatobiliary disease or history 4. Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score =15. 5. Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive. 6. (creatinine, Cr) =1.5×ULN and Cr clearance rate <60 mL/min 7. Platelet<80×10^9/L; 8. INR>1.3 9. ALB<3.5 g/dL 10. Severe pruritus or systemic medication was required within 2 months prior to randomization 11. Arrhythmia, Or during screening the QTc interval was =450 ms for male and 470 ms for female 12. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease, prior or planned (during the study period) bariatric surgery (such as gastroplasty, roux-en-Y gastric bypass). 13. Concomitant use of medications, food, and drinks that are strong or moderate CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drug and throughout the study duration. 14. Diseases that may cause non-hepatic elevation of ALP (such as Paget's disease) or may result in a life expectancy of less than 2 years 15. A history of malignant tumor within 5 years prior to randomization 16. Perazathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, and pentoxifylline were administered from 28 days before randomization to the entire clinical study period. Fenofibrate or other Bates; Budesonide and other systemic corticosteroid hormones; Hepatotoxic drugs; Liver protection Drugs and other hepatoprotective drugs were given a stable dose <28 days before randomization or could not be maintained during the trial; cholagogue 17. The administration of interleukin or other cytokine antibodies, as well as chemical factors or immunotherapy, was prohibited from 12 months prior to randomization throughout the clinical study period 18. Substance abuse or alcoholism from 6 months prior to randomization throughout the entire clinical study period 19. Poor blood pressure control is indicated by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening 20. Poor blood glucose control, that is, HBA1c >9.0% at screening 21. Pregnancy, planned pregnancy, lactation 22. Use of other investigational drugs within 3 months 23. Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital, Captail Medcial University | Beijing | Beijing |
China | Beijing Youan Hostital, Captial Medical University | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | The First Bethune Hospital of Jilin University | ChangChun | Jilin |
China | The Seconed Xiangya Hospital of Central South University | Changsha | Hunan |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
China | The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangzhou |
China | The Third Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong |
China | Shaoyifu Hospital of Zhejiang University Medical | Hangzhou | Zhejiang |
China | The First Affiliated Hospital,Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of USTC Anhui Provincial Hospital | Hefei | Anhui |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
China | Wuhan Union Hospital of China | Wuhan | Hubei |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
China | The Third People's Hospital of Zhenjiang | Zhenjiang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Cascade Pharmaceuticals, Inc |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AE incidence | AE incidence in three arms | baseline to 12 weeks | |
Primary | relative changes from baseline in ALP at week 12 | Compared with placebo ,Percentage change of CS0159 to ALP relative to baseline | baseline to 12 weeks | |
Secondary | Absulute changes from baseline in ALP at week 12 | Compared with placebo, CS0159 changes in serum ALP relative to baseline | baseline to 12 weeks | |
Secondary | ALP and TBil | Compared with placebo, the rate of subjects to achive the lelve of ALP< 1.67 ULN and (total bilirubin) TBil =ULN | baseline to 12 weeks | |
Secondary | Pruritus | the changes from baseline in Pruritus to week 40 | from basline to 40 weeks | |
Secondary | Liver function: ALT, AST, ALB, LDL-C, HDL-C, TBA, GGT, TC, TG | The reduction of ALT, AST, ALB, LDL-C, HDL-C, TBA, GGT, TC, and TG from baseline to week 40. | from baseline to week 40. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03188146 -
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
|
||
Not yet recruiting |
NCT03521297 -
Probiotics in PBC Patients of Poor Response to UDCA
|
Phase 2 | |
Recruiting |
NCT06016842 -
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
|
Phase 3 | |
Completed |
NCT04047160 -
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
|
Phase 1 | |
Completed |
NCT03124108 -
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
|
Phase 2 |