Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

NCT04650243 | Recruiting Phase 4

• 1 other identifier: ZS-2237
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis

Keywords

ursodeoxycholic acid; reducing medication regimen

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of primary biliary cholangitis

  Liver biochemical markers (AST and ALP in U/L, TBIL in umol/L) that restored to normal increase(bilirubin\>1xULN,ALP≥1.5X ULN, AST≥1.5XULN) again is considered to be PBC recurrence according to the Paris II criteria. The rate of recurrence will be described in percent.

  change from baseline to month3,6,9,12.

Study Arms (3)

10mg/Kg UDCA

EXPERIMENTAL

Patients will receive a reduced dosage of 10mg/Kg UDCA orally everyday.

Drug: ursodeoxycholic acid

5mg/Kg UDCA

EXPERIMENTAL

Patients will receive a reduced dosage of 5mg/Kg UDCA orally everyday.

Drug: ursodeoxycholic acid

standard 13-15mg/Kg UDCA

ACTIVE COMPARATOR

Patients will receive standard dosage of 13-15mg/Kg UDCA everyday.

Drug: ursodeoxycholic acid

Interventions

ursodeoxycholic acid DRUG

The two experimental groups will receive reduced dosage of UDCA at 10mg/Kg and 5mg/Kg everyday respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be at least one year.

Also known as: UDCA

10mg/Kg UDCA; 5mg/Kg UDCA; standard 13-15mg/Kg UDCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Satisfied the diagnostic criteria of PBC by the AASLDin 2000;
• Age≥18 years
• Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase);
• Patients with improved liver biochemical index( ALP and AST≤1.5× upper limit of normal, with a normal bilirubin level) after 6 to 12 months treatment of UDCA;
• Informed consent obtained.

You may not qualify if:

• 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);
• 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.;
• Participating in other clinical trials or participated in other clinical trials in three months.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Li Wang

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Wang

CONTACT

8613801175089; wangli2221@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In our study, the 90 recruited PBC patients with a complete response will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at 10mg/Kg and 5mg/Kg respectively, while the control group will receive standard 13-15mg/Kg UDCA. The effect of therapy will be evaluated every three months.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: December 2, 2020
• Study Start: January 21, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

CN (1)