Clinical Research of UCDA Reducing Medication Regimen in Stable PBC

Primary Biliary Cholangitis Clinical Trial

— UCDA PBC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650243
• Other study ID #: ZS-2237
• Status: Recruiting
• Phase: Phase 4
• Start date: March 21, 2020
• Est. completion date: October 2024

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: Li Wang
• Phone: 8613801175089
• Email: wangli2221[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of primary biliary cholangitis	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. The rate of recurrence will be described in percent.	change from baseline to month3,6,9,12,15,18,21,24,27,30,33,36,39,42,45,48,51,54,57,60