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A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

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ClinicalTrials.gov Identifier: NCT03345589
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Li Yang, West China Hospital

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) [ Time Frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid ]
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03345589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Alkaline phosphatase [ Time Frame: Week 2 and Month 1, 3, 6,9,12 ]
    (ALP)
  • Glutamyltransferase [ Time Frame: Week 2 and Month 1, 3, 6,9,12 ]
    (GGT)
  • Alanine transaminase [ Time Frame: Week 2 and Month 1, 3, 6 ]
    (ALT)
  • Aspartate transaminase [ Time Frame: Week 2 and Month 1, 3, 6, 9,12 ]
    (AST)
  • Total bilirubin [ Time Frame: Week 2 and Month 1, 3, 6, 9,12 ]
    (TB)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Official Title  ICMJE A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Brief Summary This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Biliary Cholangitis
Intervention  ICMJE
  • Drug: 18-22mg/kg/d Ursodeoxycholic
    18-22mg/kg/d Ursodeoxycholic
  • Drug: 13-15mg/kg/d Ursodeoxycholic
    13-15mg/kg/d Ursodeoxycholic
Study Arms  ICMJE
  • Experimental: 18-22mg/kg/d Ursodeoxycholic group
    Intervention: Drug: 18-22mg/kg/d Ursodeoxycholic
  • Placebo Comparator: 13-15mg/kg/d Ursodeoxycholic group
    Intervention: Drug: 13-15mg/kg/d Ursodeoxycholic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2017)
35
Estimated Study Completion Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ping Ni, MD 13281091993 545043216@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345589
Other Study ID Numbers  ICMJE PBC-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Li Yang, West China Hospital
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Li Yang, MD West China Hospital
PRS Account West China Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP