NCT02936596

Brief Summary

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 27, 2021

Status Verified

May 1, 2021

Enrollment Period

5.5 years

First QC Date

October 15, 2016

Last Update Submit

October 26, 2021

Conditions

Hepatitis, AutoimmuneCholangitisLiver Cirrhosis, BiliaryCholestasis

Outcome Measures

Primary Outcomes (1)

  • Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH)

    Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Secondary Outcomes (9)

  • Alanine transaminase (ALT)

    Week 2 and Month 1, 3, 6

  • Aspartate transaminase(AST)

    Week 2 and Month 1, 3, 6

  • Immunoglobulin G(IgG)

    Week 2 and Month 1, 3, 6

  • Globin(GLB)

    Week 2 and Month 1, 3, 6

  • Total bilirubin(TB)

    Week 2 and Month 1, 3, 6

  • +4 more secondary outcomes

Study Arms (2)

Ursodeoxycholic acid + immunosuppressive agents group

EXPERIMENTAL

Ursodeoxycholic acid + immunosuppressive agents

Drug: Ursodeoxycholic acid combination of immunosuppressive agents

Ursodeoxycholic acid group

ACTIVE COMPARATOR

Ursodeoxycholic acid

Drug: Ursodeoxycholic Acid

Interventions

Ursodeoxycholic acid combination of immunosuppressive agentsDRUG

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)

Ursodeoxycholic acid + immunosuppressive agents group
Ursodeoxycholic AcidDRUG

Ursodeoxycholic Acid

Ursodeoxycholic acid group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70 years;
  • Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening;
  • Agreed to participate in the trial, and assigned informed consent.

You may not qualify if:

  • \. The presence of hepatitis A, B, C, D, or E virus infection;
  • \. Patients with complications of cirrhosis;
  • \. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month;
  • \. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy;
  • \. Pregnant and breeding women;
  • \. Severe disorders of other vital organs, such as severe heart failure, cancer;
  • \. Parenteral administration of blood or blood products within 6 months before screening;
  • \. Recent treatment with drugs having known liver toxicity;
  • Taken part in other clinic trials within 6 months before screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hepatitis, AutoimmuneCholangitisLiver Cirrhosis, BiliaryCholestasis

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesBile Duct DiseasesBiliary Tract DiseasesCholestasis, IntrahepaticLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Li Yang, MD

    West China Hospital,Chengdu, Sichuan, China

    STUDY CHAIR

Central Study Contacts

Xiaoli Fan, MM

CONTACT

+86288542231113980433451@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master Degree

Study Record Dates

First Submitted

October 15, 2016

First Posted

October 18, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 27, 2021

Record last verified: 2021-05

Locations

CN(1)