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An Open, Randomised, Comparative, Multicentre Paediatric Clinical Trial Comparing the Efficacy and Safety of a Dual Regimen With Oral Tacrolimus (FK506) Versus a Triple Regimen With Oral Cyclosporin-Microemulsion in Primary Liver Allograft Transplantation

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.

N/A

Astellas Study ID

The unique identification code given by the study sponsor.

FG-506-01-13

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Liver Transplants

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

N/A - 16 Years

Sex

Female & Male

Product

tacrolimus

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 1997 - Dec 2000

Masking

None (Open Label)

Enrollment number

181

An Open, Randomised, Comparative, Multicentre Paediatric Clinical Trial Comparing the Efficacy and Safety of a Dual Regimen With Oral Tacrolimus (FK506) Versus a Triple Regimen With Oral Cyclosporin-Microemulsion in Primary Liver Allograft Transplantation

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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