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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

Brief Summary:
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: 18-22mg/kg/d Ursodeoxycholic Drug: 13-15mg/kg/d Ursodeoxycholic Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019


Arm Intervention/treatment
Experimental: 18-22mg/kg/d Ursodeoxycholic group Drug: 18-22mg/kg/d Ursodeoxycholic
18-22mg/kg/d Ursodeoxycholic

Placebo Comparator: 13-15mg/kg/d Ursodeoxycholic group Drug: 13-15mg/kg/d Ursodeoxycholic
13-15mg/kg/d Ursodeoxycholic




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Alkaline phosphatase [ Time Frame: Week 2 and Month 1, 3, 6,9,12 ]
    (ALP)

  2. Glutamyltransferase [ Time Frame: Week 2 and Month 1, 3, 6,9,12 ]
    (GGT)

  3. Alanine transaminase [ Time Frame: Week 2 and Month 1, 3, 6 ]
    (ALT)

  4. Aspartate transaminase [ Time Frame: Week 2 and Month 1, 3, 6, 9,12 ]
    (AST)

  5. Total bilirubin [ Time Frame: Week 2 and Month 1, 3, 6, 9,12 ]
    (TB)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345589


Contacts
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Contact: Ping Ni, MD 13281091993 545043216@qq.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Li Yang    +8618980601276    yangli_hx@scu.edu.cn   
Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: Li Yang, MD West China Hospital

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Responsible Party: Li Yang, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT03345589     History of Changes
Other Study ID Numbers: PBC-3
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Yang, West China Hospital:
Ursodeoxycholic Acid
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis