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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03345589
Enrollment
40
Registered
2017-11-17
Start date
2018-01-30
Completion date
2019-01-01
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Keywords

Ursodeoxycholic Acid

Brief summary

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

Interventions

DRUG18-22mg/kg/d Ursodeoxycholic

18-22mg/kg/d Ursodeoxycholic

DRUG13-15mg/kg/d Ursodeoxycholic

13-15mg/kg/d Ursodeoxycholic

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acidPercent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.

Secondary

MeasureTime frameDescription
Alkaline phosphataseWeek 2 and Month 1, 3, 6,9,12(ALP)
GlutamyltransferaseWeek 2 and Month 1, 3, 6,9,12(GGT)
Alanine transaminaseWeek 2 and Month 1, 3, 6(ALT)
Aspartate transaminaseWeek 2 and Month 1, 3, 6, 9,12(AST)
Total bilirubinWeek 2 and Month 1, 3, 6, 9,12(TB)

Countries

China

Contacts

Primary ContactPing Ni, MD
545043216@qq.com13281091993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026