Back to resultsA Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Primary Purpose
Primary Biliary Cholangitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
18-22mg/kg/d Ursodeoxycholic
13-15mg/kg/d Ursodeoxycholic
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Ursodeoxycholic Acid
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with primary biliary cholangitis
- Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid
Exclusion Criteria:
- Autoimmune hepatitis
- Primary sclerosing cholangitis
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
18-22mg/kg/d Ursodeoxycholic group
13-15mg/kg/d Ursodeoxycholic group
Arm Description
Outcomes
Primary Outcome Measures
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
Secondary Outcome Measures
Alkaline phosphatase
(ALP)
Glutamyltransferase
(GGT)
Alanine transaminase
(ALT)
Aspartate transaminase
(AST)
Total bilirubin
(TB)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03345589
Brief Title
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Official Title
A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
Keywords
Ursodeoxycholic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18-22mg/kg/d Ursodeoxycholic group
Arm Type
Experimental
Arm Title
13-15mg/kg/d Ursodeoxycholic group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
18-22mg/kg/d Ursodeoxycholic
Intervention Description
18-22mg/kg/d Ursodeoxycholic
Intervention Type
Drug
Intervention Name(s)
13-15mg/kg/d Ursodeoxycholic
Intervention Description
13-15mg/kg/d Ursodeoxycholic
Primary Outcome Measure Information:
Title
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
Description
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
Time Frame
Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid
Secondary Outcome Measure Information:
Title
Alkaline phosphatase
Description
(ALP)
Time Frame
Week 2 and Month 1, 3, 6,9,12
Title
Glutamyltransferase
Description
(GGT)
Time Frame
Week 2 and Month 1, 3, 6,9,12
Title
Alanine transaminase
Description
(ALT)
Time Frame
Week 2 and Month 1, 3, 6
Title
Aspartate transaminase
Description
(AST)
Time Frame
Week 2 and Month 1, 3, 6, 9,12
Title
Total bilirubin
Description
(TB)
Time Frame
Week 2 and Month 1, 3, 6, 9,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with primary biliary cholangitis
Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid
Exclusion Criteria:
Autoimmune hepatitis
Primary sclerosing cholangitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Ni, MD
Phone
13281091993
Email
545043216@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang
Phone
+8618980601276
Email
yangli_hx@scu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
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