Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatri
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
| Condition(s) | Liver Transplant |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients. |
| Who can participate | Inclusion Criteria: 1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations; 2. Able to completely swallow capsules; 3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment; 4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers; 5. Undergo a programmed liver biopsy; Exclusion Criteria: 1. Multi-organ combined transplantation or multiple liver transplantation; 2. Adjuvant liver transplantation or use of bioartificial liver therapy; 3. ABO incompatible children with liver transplantation; 4. Allergic to tacrolimus; 5. Participation in any other clinical study within 3 months prior to enrollment; 6. Use of tacrolimus sustained release caps |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Lead sponsor | RenJi Hospital |
| Locations | Shanghai, China |
| Start date | 2024-03-04 |
| NCT ID | NCT06183892 |
| Official listing | https://clinicaltrials.gov/study/NCT06183892 |