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infantile cholestatic liver disease

Efficacy and safety of glucocorticoids in the treatment of infantile cholestatic liver disease in Han Chinese: A randomized trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033051
Enrollment
Unknown
Registered
2020-05-19
Start date
2018-01-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

infantile cholestatic liver disease

Interventions

Experimental group:Conventional treatment plus glucocorticoid
Control group:Conventional treatment

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnostic criteria: The diagnosis of cholestasis followed the 2004 North American Gastroenterological Societys diagnostic criteria: 1. When total infant bilirubin level >=85.5 umol/L and the ratio of DBIL to TBIL is >20%; 2. When infant serum bilirubin level is 17.1 umol/L. Inclusion criteria: 1. Onset age =28 days; 2. Liver texture is hardened, liver size >2 cm; 3. ALT and AST levels are elevated.

Exclusion criteria

Exclusion criteria: 1. Congenital biliary tract abnormalities, such as biliary atresia and common bile duct cyst; 2. Hepatobiliary tumor; 3. Contraindications to GC application, such as severe infection or innate immune deficiency.

Design outcomes

Primary

MeasureTime frame
Liver function;

Countries

China

Contacts

Public ContactLing-fen Xu

Shengjing Hospital of China Medical University

xulingfen7408@163.com+86 18940257408

Outcome results

None listed

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