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Multi-center clinical study of individualized immunosuppressive drugs after liver transplantation in children in China

Effectiveness of Immune Cell Function Assay in Monitoring Immunity of Children after Liver Transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015089
Enrollment
Unknown
Registered
2018-03-07
Start date
2017-04-10
Completion date
Unknown
Last updated
2018-03-12

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

Conditions

liver transplantation

Interventions

experimental group and control group:The patients with liver transplantation within 3 years of age and below were selected before surgery for Cylex ATP as the baseline value. After liver transplantati

Sponsors

Renji Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. the patient's family members voluntarily signed informed consent and have been verbally informed of specific test programs; 2. Chinese nationality; 3. children younger than 3 years old with primary liver transplantation.

Exclusion criteria

Exclusion criteria: 1. the combination of drugs containing drugs that affect CYP3A activity, such as erythromycin, itraconazole and so on; 2. other research drugs were used within 4 weeks before enrollment; 3. transplant or multiple organ transplant children again; 4. suffering from severe anemia, severe malnutrition, intestinal absorption disorders affect drug metabolism disease, or other surgical complications were judged by the researchers as follow-up assessment of the impact of the study; 5. the initial medication for other CNI drugs, into children with tacrolimus; 6. the use of tacrolimus or cyclosporine serious adverse reactions need to switch other immunosuppressive agents.

Design outcomes

Primary

MeasureTime frame
Incidence of acute rejection. (biopsy proven or clinical AR);Percentage of transplant-related infectious diseases occurred;

Secondary

MeasureTime frame
Correlation of Cylex ATP results with immunosuppressive efficacy (stabilization / rejection / infection);Survival of patients and grafts;

Countries

China

Contacts

Public ContactXia Qiang

Liver Surgery Department, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

xiaqiang@medmail.com.cn+86 21 68383775

Outcome results

None listed

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