Clinical Trials Logo
  1. Home
  2. Primary Biliary Cholangitis
  3. NCT03322943
  4. Details
NCT03322943 Clinical Trial

The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Primary Biliary Cholangitis Clinical Trial

Official title:
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03322943
Other study ID # PBC-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 30, 2018

Study information
Verified date March 2019
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria:

Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year

Exclusion Criteria:

Autoimmune hepatitis Primary sclerosing cholangitis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Description of demographics, clinical index after treatment age,sex,ALT(IU/L),AST(IU/L),ALP(IU/L),GGT(IU/L),IgG(g/L) up to 1 year
Secondary Evaluation whether the PBC patients have response after treatment Use Paris II criterion to estimate within 1 year
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 NCT04076527 - Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Recruiting NCT05151809 - National Database 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
Completed NCT05292872 - Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients