Actively Recruiting
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
Led by Cascade Pharmaceuticals, Inc · Updated on 2025-12-30
135
Participants Needed
41
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).
CONDITIONS
Official Title
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years, male or female
- Written informed consent given
- Diagnosed with Primary Biliary Cholangitis (PBC) by at least two criteria: ALP above 1.0 times ULN for 6 months or more, positive antimitochondrial or PBC-specific antinuclear antibodies, or liver biopsy consistent with PBC
- Treated with UDCA for 6 months before randomization with stable dose for 3 months if response was poor, or unable to tolerate UDCA and stopped it for at least 3 months before randomization
- Laboratory criteria at screening including ALP ≥1.67 times ULN, ALT ≤5 times ULN, AST ≤5 times ULN, total bilirubin <2 times ULN, eGFR >60 mL/min/1.73m2, INR ≤1.0 times ULN (or maintained if on anticoagulation), platelet count ≥150 x 10^9/L, albumin >35 g/L, WBC >3 x 10^9/L, ANC >1.5 x 10^9/L, HbA1c ≤9.0%
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during and for 90 days after the study; sexually active males with female partners must also use barrier contraception with their partners using a second method
You will not qualify if you...
- Previous exposure to CS0159
- Allergy to CS0159 or similar drugs
- Advanced PBC defined by Rotterdam criteria (albumin <1.0 times LLN and total bilirubin >1.0 times ULN)
- Significant complications of liver cirrhosis or portal hypertension such as liver transplant history, MELD-Na score ≥12, variceal bleeding, ascites requiring treatment, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic hydrothorax, hepatic encephalopathy, portopulmonary hypertension, hepatopulmonary syndrome, or hepatocellular carcinoma
- Other liver diseases including autoimmune hepatitis, PBC-AIH overlap, positive hepatitis B or C virus markers, primary sclerosing cholangitis, alcoholic liver disease, non-alcoholic steatohepatitis, Gilbert's Syndrome, alpha-1 antitrypsin deficiency, or liver stiffness >16.9 Kpa
- Positive HIV test or active syphilis
- Use of certain medications as specified within defined timeframes before randomization
- Medical conditions causing non-liver ALP increases
- Severe arrhythmia or prolonged QTc interval
- Diseases affecting drug absorption or metabolism such as inflammatory bowel disease or bariatric surgery
- History or current malignancy except certain cured skin or cervical cancers
- Drug abuse or heavy alcohol use in past 12 months
- Poorly controlled blood pressure
- Pregnancy, planned pregnancy, or lactation
- Recent participation in other investigational treatments
- Mental instability or inability to comply with study
- Any other condition that may compromise patient safety or study quality as judged by investigator
AI-Screening
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Trial Site Locations
Total: 41 locations
1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
4
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
Not Yet Recruiting
5
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
7
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
8
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
9
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
10
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
11
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Not Yet Recruiting
12
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Not Yet Recruiting
13
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Not Yet Recruiting
14
The Fourth Hospital Of Harbin Medical University
Harbin, Heilongjiang, China
Not Yet Recruiting
15
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
16
Taihe Hospital of Shiyan
Shiyan, Hubei, China
Not Yet Recruiting
17
Xiangya Hospital Central South University
Changsha, Hunan, China
Not Yet Recruiting
18
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
19
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Not Yet Recruiting
20
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
Not Yet Recruiting
21
The Fifth People's Hospital Of Wuxi
Wuxi, Jiangsu, China
Not Yet Recruiting
22
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
Not Yet Recruiting
23
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
24
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
25
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Not Yet Recruiting
26
The First Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
27
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Not Yet Recruiting
28
Baoji People's Hospital
Baoji, Shaanxi, China
Not Yet Recruiting
29
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Not Yet Recruiting
30
Linyi People's Hospital
Linyi, Shandong, China
Not Yet Recruiting
31
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Not Yet Recruiting
32
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
33
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
34
Xin Hua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
35
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
36
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
37
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
38
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
39
Hangzhou Xixi Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
40
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Not Yet Recruiting
41
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
M
Ma Xiong, MD
CONTACT
X
Xiao Xiao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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