Clinical Trials Logo
  1. Home
  2. Primary Biliary Cholangitis
  3. NCT06371196

Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule

Primary Biliary Cholangitis Clinical Trial

Official title:
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule

Clinical Trial Summary

1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.

Clinical Trial Description

1. Primary objective: to investigate the effect of Baobao Dan capsule on serum total bilirubin levels in patients with primary biliary cholangitis with elevated total serum bilirubin. 2. Secondary objective: to observe the effects of Babaodan Capsule on the following aspects in patients with primary biliary cholangitis with elevated total bilirubin: (1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06371196
Study type Interventional
Source Beijing University of Chinese Medicine
Contact Lin Shuiping
Phone 136660698451
Email linsp@dinglu.com.cn
Status Not yet recruiting
Phase Phase 4
Start date April 25, 2024
Completion date December 31, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT02516605 - A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients Phase 2
Recruiting NCT06051617 - Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Phase 3
Recruiting NCT06060665 - IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Recruiting NCT05450887 - Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis Phase 3
Recruiting NCT05050136 - A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Phase 2
Recruiting NCT05151809 - National Database on Primary Biliary Cholangitis
Recruiting NCT04076527 - Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Recruiting NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Phase 1
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Completed NCT06098027 - Study of [14C]CS0159 in China Healthy Subjects Phase 1
Active, not recruiting NCT04594694 - Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC Phase 2
Completed NCT03602560 - ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Suspended NCT03684187 - Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis N/A
Recruiting NCT04617561 - Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II Phase 4
Terminated NCT03092765 - Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid Phase 2
Completed NCT04604652 - Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Phase 2
Not yet recruiting NCT06417398 - Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases Early Phase 1
Recruiting NCT05919433 - Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Completed NCT06309589 - The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis N/A
Withdrawn NCT05293938 - A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients