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A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de novo Liver transplant recipients.

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.
NCT00720408

Astellas Study ID

The unique identification code given by the study sponsor.

PRGXLLTx-0702-TW

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

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Condition

Liver Transplants, Immune Response after Transplants, Transplant Rejection

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

18 Years - 70 Years

Sex

Female & Male

Product

N/A

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

Dec 2007 - Sep 2009

Masking

None (Open Label)

Enrollment number

48

A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF and steroid withdraw in de novo Liver Transplant Recipients.

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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