The use of Myfortic in paediatric patients after liver transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001830-34-GB

Enrollment

Registered

2005-04-29

Start date

2005-08-18

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

Liver transplantation

Interventions

Trade Name: Myfortic Product Name: Myfortic Product Code: ERL080 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: mycop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Group 1: high risk for kidney dysfunction or pre-existing kidney dysfunction (GFR =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Parental consent and child assent has not been ascertained, pregnancy (all sexually active girls >12 years will have a pregnancy test prior to starting the study drug); hypersensitivity to mycophenolate

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the saftey and efficacy of Myfortic in children who are at risk of renal dysfunction after liver transplantion, either as primary immunosuppression in conjunction with tacrolimus immediately after transplantation (Group 1) or conversion from Mycophenolate Mofetil (MMF) to Myfortic in children who are intolerant to MMF (Group 2);Secondary Objective: Pharmacokinetics;Primary end point(s): The end point in both groups will be monitored at one year after commencing Myfortic. These include renal dysfunction (GFR), incidence of rejection and incidence of infection (bacterial, viral, fungal)	—

Measure

Time frame

Main Objective: To study the saftey and efficacy of Myfortic in children who are at risk of renal dysfunction after liver transplantion, either as primary immunosuppression in conjunction with tacrolimus immediately after transplantation (Group 1) or conversion from Mycophenolate Mofetil (MMF) to Myfortic in children who are intolerant to MMF (Group 2);Secondary Objective: Pharmacokinetics;Primary end point(s): The end point in both groups will be monitored at one year after commencing Myfortic. These include renal dysfunction (GFR), incidence of rejection and incidence of infection (bacterial, viral, fungal)

—

Countries

United Kingdom

Outcome results

None listed

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