UnknownPhase 4

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

China90 participantsStarted 2020-11-01

Plain-language summary

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients aged 18-75 years;
✓. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN \< ALT \< 5xULN or 3xULN \< AST \< 5xULN or 1.3xULN \< IgG \< 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation;
✓. Agreed to participate in the trial, and assigned informed consent.

Exclusion criteria

✕. The presence of hepatitis A, B, C, D, or E virus infection;
✕. Patients with presence of cirrhosis;
✕. Patients with presence of fulminant liver failure;
✕. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease; Pregnant and breeding women and women of childbearing age in need of reproduction;
✕. 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 enrollment.

What they're measuring

Biochemical remission

Timeframe: up to 12 months

Trial details

NCT IDNCT04617561

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-01

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