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A Single-arm Intervention Study of a Three-stage Immunosuppression Minimizition /Elimination (Hep-TIME) Strategy in Long-term Liver Transplant Recipients

A Single-arm Intervention Study of a Three-stage Immunosuppression Minimizition /Elimination (Hep-TIME) Strategy in Long-term Liver Transplant Recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116142
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-10
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Post-liver transplantation status

Interventions

Immunosuppression Minimizition /Elimination Group:Three-stage Immunosuppression Minimizition /Elimination (Hep-TIME) Strategy

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years; 2. More than 3 years after liver transplantation; 3. Maintenance therapy using only tacrolimus and/or sirolimus; 4. Medication dose less than 2 mg and drug concentration less than 5.0 ng/ml; 5. No rejection episodes in the past year; 6. Primary disease is not autoimmune hepatitis; 7. Liver biopsy confirms no subclinical rejection or significant fibrosis changes; 8. No active HBV or HCV infection; 9. No plans for pregnancy; 10. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined organ transplantation, ABO-incompatible liver transplantation, living donor liver transplantation, and secondary (multiple) liver transplantation; 2. With active infections; 3. With vascular or biliary complications; 4. With recurrent or new tumors; 5. Unable to follow up on time; 6. Having other diseases that require the use of immunosuppressants; 7. Drug or alcohol abuse; 8. Accompanied by other unstable chronic diseases.

Design outcomes

Primary

MeasureTime frame
Immune elimination success rate;

Secondary

MeasureTime frame
5-year survival rate;Immune minimization success rate;Immune minimization failure rate;Alleviation of immunosuppressant-related adverse effects;Graft loss rate;

Countries

China

Contacts

Public ContactQiu Wei

The First Hospital of Jilin University

qiuwei@jlu.edu.cn+86 431 8878 5177

Outcome results

None listed

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