Investigating immune tolerance in children after liver transplantation
Immune Tolerance After Pediatric Liver transplantation-a Cohort Study
RenJi Hospital · NCT05501301
This study is testing how well children's immune systems can accept a new liver without medication after a liver transplant to see if it's safe and effective for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05501301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the ratio and safety of spontaneous immune tolerance in pediatric liver transplantation recipients. It focuses on children aged 4 months to 18 years who have undergone living donor liver transplantation and have maintained stable liver function for over three months. The study will monitor participants who are either on monotherapy of immunosuppressive agents or have ceased taking them altogether. By constructing an immune tolerance cohort, the research seeks to understand the factors contributing to immune tolerance and its long-term safety.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 months to 18 years who have undergone living donor liver transplantation and have stable liver function.
Not a fit: Patients with tumors, hepatitis virus infections, or those who have undergone ABO incompatible or multiple organ transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced reliance on immunosuppressive medications, minimizing long-term side effects for pediatric liver transplant recipients.
How similar studies have performed: While the concept of immune tolerance in liver transplantation has been explored, this specific approach focusing on pediatric patients and long-term safety is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age at liver transplantation: 4 months to 18 years; 2. Original disease before liver transplantation: End-stage liver diseases including cholestatic diseases or metabolic diseases; 3. Type of liver transplantation: living donor liver transplantation, with donors of recipient's parents 4. Follow-up time after liver transplantation: more than one year 5. Liver function: liver function maintains normal and stable 3 months before enrollment 6. IS strategy: monotherapy of IS (FK or cyclosporine) or no longer taking any IS 7. Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\<2) 8. Written consents are required Exclusion Criteria: 1. Original disease before liver transplantation: Tumor, hepatitis virus infection, autoimmune hepatitis, liver failure, secondary liver transplantation 2. Type of liver transplantation: ABO incompatible liver transplantation, donors are not recipient's parents or multiple organ transplantation 3. Hepatitis virus infection during follow-up 4. Severe compilations, including bleeding complication, biliary complication, vessel complication or renal dysfunction -
Where this trial is running
Shanghai, Shanghai
- Ren Ji Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Yuan Liu, MD
- Email: liuyuanbird@163.com
- Phone: 13651733680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immune Tolerance, Liver Transplant, Complications, immune tolerance, pediatric liver transplantation