A Phase II Study to Evaluate Safety, Tolerability and Efficacy, of CS0159 in Patients Subjects With Primary Sclerosing Cholangitis, Multicenter, Randomized, 12-week Double-blind, Placebo-controlled, and 40-week Open Study
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female age≥18 or age≤75 years when sign ICF
• 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
• 1.50×ULN≤ALP≤10×ULN, and TBil≤3×ULN during screen
• Taken UDCA(≤25mg/kg/d)≥6 months before randomization and stable does≥ 3 months, or not used UDCA≥3 months before randomization
• For subject with a history of IBD
‣ Patients with Crohn's Disease (CD),Must be in remission, CDAI\<150 or CDAI of score ≤4
⁃ Patients with(Ulcerative Colitis)UC,Must be in remission or only mild activity,Some Mayo scores range from 0 to 4
• Be able to understand and Comply with the study protocol sign a written informed consent form(ICF)voluntarily
Locations
Other Locations
China
Beijing Friendship Hospital, Captail Medcial University
RECRUITING
Beijing
Beijing YouAn Hostital, Captial Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
The Seconed Xiangya Hospital of Central South University
RECRUITING
Changsha
Shaoyifu Hospital of Zhejiang University Medical
RECRUITING
Hangzhou
The First Affiliated Hospital,Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of USTC Anhui Provincial Hospital
RECRUITING
Hefei
Qilu Hospital of Shandong University
RECRUITING
Jinan
Renji Hospital, Shanghai Jiao Tong University School of Medicine