Biochemical response of PBC-AIH overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-16008935

Enrollment

Unknown

Registered

2016-07-28

Start date

2014-01-31

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PBC-AIH overlap syndrome

Interventions

UDCA+IS group:UDCA+IS

UDCA only:UDCA only

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–70 years; 2. Diagnosed with PBC-AIH according to Paris criteria, based on liver biopsy results obtained 3 months before screening; 3. Agreed to participate in the trial, and assigned informed consent.

Exclusion criteria

Exclusion criteria: 1. The presence of hepatitis A, B, C, D, or E virus infection; 2. Patients with complications of cirrhosis; 3. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine; 4. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,Drug induced liver disease or Wilson disease comfirmed by lier biopsy; 5. Pregnant and breeding women; 6. WBC<2.5x10^9/L or PLT<50x10^9/L; 7. Severe disorders of other vital organs, such as severe heart failure, cancer; 8. Parenteral administration of blood or blood products within 6 months before screening; 9. Recent treatment with drugs having known liver toxicity; 10. Taken part in other clinic trials within 6 months before screening.

Design outcomes

Primary

Measure	Time frame
biochemical response rate;	—

Secondary

Measure	Time frame
side effects;	—

Countries

China

Contacts

Public ContactLi Yang

West China Hospital, Sichuan University

yangli_hx@scu.edu.cn+86 0 18980601276

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026