BIG STEP

Phase 2

• Conditions: Primary Biliary Cholangitis; Cholangitis

• Registration Number: JPRN-jRCTs051210210
• Lead Sponsor: Fujinaga Yukihisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-30
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Primary biliary cholangitis
2. 20 years old or older at the time of consent acquisition
3. Patients with performance status (ECOG) 0 or 1
4. Patients without dose change of ursodeoxycholic acid (UDCA) and fibrate
5. Patients who received sufficient explanation about the contents of this study and voluntarily obtained written consent from the study subject or the surrogate

Exclusion Criteria

1. Patients with hypersensitivity to hesperidin
2. Patients who routinely take health foods containing hesperidin before participating in this study
3. Patients scheduled or under treatment for malignant tumors
4. Patients with NYHA functional classification 2 or higher
5. Patients who become aware of dyspnea during daily exertion
6. Patients with a total bilirubin level of 3.0 mg / dl or higher or Child-Pugh classification B or C
7. Patients with eGFR <30 mL / min / 1.73 m2
8. Patients who are pregnant or may be pregnant
9. Patients who participated in other clinical trials (clinical trials) within 3 months before the start of hesperidin administration
10. Patients judged by doctors to be inappropriate as research subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified