Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis

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ClinicalTrials.gov Identifier: NCT04650243

Recruitment Status : Recruiting

First Posted : December 2, 2020

Last Update Posted : December 2, 2020

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Sponsor:

Information provided by (Responsible Party):

Peking Union Medical College Hospital

Study Description

Brief Summary:

This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.

Condition or disease	Intervention/treatment	Phase
Primary Biliary Cholangitis	Drug: ursodeoxycholic acid	Phase 4

Detailed Description:

Primary biliary cholangitis is a chronic, progressive liver disease of autoimmune origin characterized by nonpurulent destruction of intrahepatic ductule, lymphatic infiltration of portal area and long-term intrahepatic cholestasis leading to liver fibrosis and cirrhosis in absence of treatment. The diagnosis is made in the presence of antimitochondrial antibodies (AMA) coupled with an increase in alkaline phosphatase (ALP), a histologic confirmation being mandatory only in seronegative cases or overlap syndrome. Treatment is based on ursodeoxycholic acid (UDCA) and obeticholic acid, which are proved effective in improving biochemical index and preventing disease progression. While obeticholic acid is only approved in USA and Canada, UDCA seem to be the only choice for PBC patients in China. Study has shown that liver function improvement can be expected in six to nine months when patients receive standard dosage( 13 -15mg/kg/d) of UDCA. Recovery of liver function takes two years in 20% of patients ,and five years in 15% to 35% of patients. Lifetime medication is recommended among patients with good respond to UDCA, while the high cost has placed great burden on patients as well as the medical service system. Exploration of the reducing medication regimen of UDCA among stable PBC patients is of great significance under this circumstance. In our study, the 90 recruited patients of refractory PBC will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months, which includes assessment of symptoms, life quality, disease progression, complete blood count, urinalysis, liver biochemical markers (ALT, AST, ALP, GGT, TBIL, DBIL, TP, ALB), blood lipid (CHO, TG, LDL, HDL), immunoglobulins, ESR, AMA, liver morphology and cirrhosis degree, along with peripheral T lymphocyte subpopulations and cytokines test.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	In our study, the 90 recruited patients of refractory PBC will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.
Masking:	Double (Investigator, Outcomes Assessor)
Masking Description:	The specimen and information collectors will also be masked in the clinical trial
Primary Purpose:	Treatment
Official Title:	Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis
Actual Study Start Date :	March 21, 2020
Estimated Primary Completion Date :	October 2024
Estimated Study Completion Date :	October 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Medicines

Drug Information available for: Ursodiol

Genetic and Rare Diseases Information Center resources: Primary Biliary Cholangitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: ursodeoxycholic acid 250mg bid Patients will receive a reduced dosage of ursodeoxycholic acid 250mg orally twice a day.	Drug: ursodeoxycholic acid The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be five years. Other Name: UDCA
Experimental: ursodeoxycholic acid 250mg qd Patients will receive a reduced dosage of ursodeoxycholic acid 250mg orally once a day.	Drug: ursodeoxycholic acid The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be five years. Other Name: UDCA
Active Comparator: ursodeoxycholic acid standard dosage Patients will receive standard dosage of ursodeoxycholic acid 250mg orally three times a day.	Drug: ursodeoxycholic acid The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be five years. Other Name: UDCA

Outcome Measures

Primary Outcome Measures :

Recurrence rate of primary biliary cholangitis [ Time Frame: change from baseline to month3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60 ]
Liver biochemical markers (AST and ALP in U/L, BIL in umol/L) that restored to normal increase(bilirubin>17μmol/L,ALP>3 ULM, AST>2 ULN) again is considered to be PBC recurrence

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Satisfied the diagnostic criteria of PBC by the AASLDin 2000;
Aged 18-65 years old;
Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase);
Patients with improved liver biochemical index(i.e. bilirubin≤17μmol/L, ALP≤3ULN, and AST≤2ULN) for at least 6 months after 6 to 12 months treatment of UDCA;
Informed consent obtained.

Exclusion Criteria:

Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN;
Decompensation of liver function (Child grade B/C);
Combined with other autoimmune diseases;
Complicated with important organ failure (such as renal insufficiency), serious infection or other serious complications;
Pregnancy, preparation for pregnancy or pregnancy Lactation, psychiatric subjects, etc.;
Combined with tumor;
Participating in other clinical trials or participated in other clinical trials in three months.

Contacts and Locations

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): NCT04650243

Contacts

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Contact: Li Wang	8613801175089	wangli2221@sina.com

Locations

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China
Peking Union Medical College Hospital	Recruiting
Beijing, China
Contact: Li Wang 8613801175089 wangli2221@sina.com
Principal Investigator: Li Wang

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

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Study Director:	Li Wang	Peking Union Medical College Hospital

More Information

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Responsible Party:	Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:	NCT04650243
Other Study ID Numbers:	ZS-2237
First Posted:	December 2, 2020 Key Record Dates
Last Update Posted:	December 2, 2020
Last Verified:	March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	all IPD that underlie results in a publication
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Time Frame:	within 6 months after the trial complete
Access Criteria:	IPD will be shared by Excel within six months after the trial complete with the public

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Peking Union Medical College Hospital:


ursodeoxycholic acid reducing medication regimen

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 Fibrosis Pathologic Processes Ursodeoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents

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