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A study to assess the pharmacokinetics, safety and efficacy of Advagraf and Prograf in de novo liver 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.
NCT01339468

Astellas Study ID

The unique identification code given by the study sponsor.

MR-08-04-KOR_Main

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

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

20 years - N/A

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

Apr 2011 - May 2014

Masking

None (Open Label)

Enrollment number

100

A phase IV, randomized, open-label, comparative, single-center study to assess the pharmacokinetics, safety and efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de novo living donor 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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