A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year

NCT ID: NCT02143479

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-18

Study Completion Date

2017-05-03

Brief Summary

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A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1:early conversion from Prograf® to Advagraf®

patients converted from Prograf® to Advagraf® in the first 3 months after transplantation

Tacrolimus

Intervention Type DRUG

oral

2:late conversion from Prograf® to Advagraf®

patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation

Tacrolimus

Intervention Type DRUG

oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf Advagraf

Eligibility Criteria

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Inclusion Criteria

* Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.

Exclusion Criteria

* Patient participating in an interventional clinical trial at the time of enrolment into the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma S.A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical and Scientific Affairs Manager, Transplantation

Role: STUDY_DIRECTOR

Astellas Pharma S.A.S.

Locations

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Site

Besançon, , France

Site Status

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Bordeaux, , France

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Caen, , France

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Chambray-lès-Tours, , France

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Clichy, , France

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Créteil, , France

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Grenoble, , France

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Lille, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Rennes, , France

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Toulouse, , France

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Villejuif, , France

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Countries

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France

Other Identifiers

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FR-ADV-NI-002

Identifier Type: -

Identifier Source: org_study_id

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