A randomised pilot trial of a steroid-free immunosuppressant regimen in paediatric liver transplantation - A pilot trial of paediatric liver transplantation without steroids

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004822-26-GB

Enrollment

Registered

2007-11-26

Start date

2007-12-20

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Post isolated liver transplant complications

Interventions

Trade Name: Prednisolone Product Name: Prednisolone Pharmaceutical Form: INN or Proposed INN: PREDNISOLONE CAS Number: 50248

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children undergoing primary isolated hepatic transplantation. Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Children undergoing retransplantation. Transplantation for Intestinal failure associated liver disease. Multi-organ transplantation. Transplantation for autoimmune liver disease. Transplantation for extra hepatic malignancy. Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objectives are to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following paediatric liver transplantation. ; Secondary Objective: 1. The development of steroid resistant acute rejection 2. The expression of tissue and circulating markers of immune tolerance in first year post transplant 3. The incidence of infection in the first year post transplant ;Primary end point(s): The development of histologically proven acute rejection. (within 12 months)	—

Measure

Time frame

Main Objective: The overall objectives are to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following paediatric liver transplantation. ; Secondary Objective: 1. The development of steroid resistant acute rejection 2. The expression of tissue and circulating markers of immune tolerance in first year post transplant 3. The incidence of infection in the first year post transplant ;Primary end point(s): The development of histologically proven acute rejection. (within 12 months)

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Countries

United Kingdom

Outcome results

None listed

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