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Precision medicine research in the application of immunosuppressive agents for pediatric liver transplantation in China

Precision medicine research in the application of immunosuppressive agents for pediatric liver transplantation in China

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035792
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

liver disease

Interventions

Experimental group:Adjust the dose of immunosuppressive agent according to Cylex ATP value combined with drug concentration
Control group:Adjust the dose of tacrolimus or cyclosporine according to "Guidelines for Clinical Diagnosis and Treatment of pediatric Liver Transplantation (2015 Edition)''
PKPD group:Tacrolimus intervention

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The family members of the patients voluntarily signed the informed consent form and were orally informed of the specific test plan; 2) Chinese nationality; 3) The age of children undergoing first liver transplantation is between 5 and 36 months; 4) Weigh 5 kg or more.

Exclusion criteria

Exclusion criteria: 1) Children undergoing retransplantation or multi-organ transplantation; 2) Preoperative severe acute liver failure and emergency liver transplantation were considered excluded; 3) Children undergoing liver transplantation due to liver tumor; 4) ABO-incompatible liver transplantation; 5) The drug combination that affect the activity of CYP3A, such as erythromycin and itraconazole; 6) Children with different immunosuppressive regimens, such as sulai induction.

Design outcomes

Primary

MeasureTime frame
Post-transplant infection;

Secondary

MeasureTime frame
acute rejection;Population Pharmacokinetics;

Countries

China

Contacts

Public ContactXia Qiang

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

yyzs_0@126.com+86 021-58737232

Outcome results

None listed

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