MedTrace Logo

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

NCT01371344 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-11-01

No results posted yet for this study

Summary

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

Conditions

  • Heart Transplantation
  • Kidney Transplantation
  • Liver Transplantation

Interventions

DRUG

Tacrolimus granules

oral

DRUG

Tacrolimus capsules

oral

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Senior Study Manager · Astellas Pharma Europe Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-24
Primary Completion
2017-04-02
Completion
2017-04-02

Countries

  • Belgium
  • France
  • Germany
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01371344 on ClinicalTrials.gov