CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)
NCT ID: NCT05896137
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2023-08-07
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)
NCT05896124
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
NCT05624294
Study of [14C]CS0159 in China Healthy Subjects
NCT06098027
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
NCT07282353
Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
NCT01688024
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2mg CS0159
CS0159 tablet 2mg for 12 weeks
CS0159
Oral QD
4mg CS0159
CS0159 tablet 4mg for 12 weeks
CS0159
Oral QD
Placebo
Placebo for 12 weeks
CS0159
Oral QD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CS0159
Oral QD
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Within the last year, have a clinical diagnosis of PSC with a consistent magnetic resonance cholangiopancreatography (MRCP) orendoscopic retrograde cholangiopancreatography (ERCP) Prcutaneous Transhepatic Cholangiography(PTC) showing sclerosing cholangitis
3. 1.50×ULN≤ALP≤10×ULN, and TBil≤3×ULN during screen
4. Taken UDCA(≤25mg/kg/d)≥6 months before randomization and stable does≥ 3 months, or not used UDCA≥3 months before randomization
5. For subject with a history of IBD
1. Patients with Crohn's Disease (CD),Must be in remission, CDAI\<150 or CDAI of score ≤4
2. Patients with(Ulcerative Colitis)UC,Must be in remission or only mild activity,Some Mayo scores range from 0 to 4
6. Be able to understand and Comply with the study protocol sign a written informed consent form(ICF)voluntarily
Exclusion Criteria
2. Small duct PSC
3. ALT or AST\>5×ULN
4. Taken( ObeticholicAcid) OCA within 3 months before randomization
5. Acute cholangitis was suspected or confirmed within 3 months prior to randomization, Including acute cholangitis being treated during screening
6. Presence of percutaneous drain or bile duct stent at the time of screening or during the study
7. Known concurrent comorbidities with other hepatobiliary diseases including, but not limited to: active hepatitis B virus or hepatitis C virus infection (see Exclusion Criterion 9), primary biliary cholangitis, complete biliary obstruction, acute cholecystitis or gallstones with significant symptoms, Autoimmune Hepatitis (AIH) or overlap with other autoimmune liver diseases, Alcoholic Hepatitis, Non-Alcoholic Steatohepatitis, Suspected or Diagnosed Primary Hepatocellular Cancer, and Bile Duct Cancer;
8. Child-Pugh patients with grade B or C cirrhosis,Present complications related to cirrhosis or End-stage liver disease ,Including history of liver transplantation Preparing for liver transplantation (Model for End-Stage Liver Disease)MELD≥15，Portal hypertension complications,Complications of cirrhosis
9. Patients who are HBsAg-positive, HCVAb-positive, HIVAb-positive or TPAb-positive at screening
10. Cr(Creatinine)≥1.5×ULN also Cr(Creatinine)clearance rate\<60 mL/min
11. PLT(Platelet)\<80×10\^9/L
12. INR(international normalized ratio)\>1.3
13. ALB\<3.5g/dL
14. Severe pruritus may require systemic medication Within 2 months prior to randomization
15. Arrhythmia,male QTc≥450 ms,female QTc≥470 ms, during screening
16. A disease that interferes with the absorption, distribution, metabolism, or excretion of a test drug,such as moderate to severe activity IBD patient, Previous gastric bypass surgery
17. Moderate or intense inhibition of CYP3A4 was performed during 14 days prior to randomization and throughout the trial Preparation or inducer
18. The presence of diseases that may cause non-hepatic elevation of ALP (e.g. Paget's disease) or may cause it Diseases with a life expectancy of less than 2 years
19. History of malignancy within the past 5 years prior to randomization
20. Immunosuppressants, budesonide, and other systemic glucocorticoids were used within 28 days before randomization and throughout the clinical study period;
21. Use of fenofibrate or another fibrate within 28 days prior to randomization and throughout the clinical study period; Hepatotoxic drugs; Hepatoprotective drugs and other hepatoprotective drugs were given stable doses \<28 days before randomization or could not maintain stable doses during the trial; cholagogue
22. Interleukin or other cytokines were used 12 months before randomization and throughout the trial Or antibodies to chemokines or immunotherapy
23. Drug and/or alcohol abuse within the first six months of randomization
24. Poor blood pressure control,systolic pressure\>160 mmHg or dpb \>100 mmHg
25. Poor blood sugar control,Glycated hemoglobin\>9.0%
26. Females who are pregnant or plan to pregnant,Fertile but refusing to sign informed consent, or breastfeed
27. Participated any other study within 30 days prior randomization,and received other experimental medications therapy
28. It is unsuitable to participate for the study or has other diseases by the investigator
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cascade Pharmaceuticals, Inc
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rong Deng
Role: STUDY_DIRECTOR
Cascade Pharmaceuticals, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Captail Medcial University
Beijing, Beijing Municipality, China
Beijing YouAn Hostital, Captial Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
The Seconed Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shaoyifu Hospital of Zhejiang University Medical
Hangzhou, Zhejiang, China
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
He Hong Liang
Role: primary
You Hong
Role: primary
Zheng Su Jun
Role: primary
Yang Ai Ming
Role: primary
Zhang Wen
Role: primary
Lin Rong
Role: primary
Zhang Min
Role: primary
Wang Kai
Role: primary
Ma Xiong
Role: primary
Cao Qian
Role: primary
Liang Tin Bo
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PSC-CS0159-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.