Trials Sponsors Conditions Drugs Pricing

Conditions

Liver Transplantation Transplantation Immunology Host vs Graft Reaction

Keywords

ImmunosuppressantGraft lossCombination drug therapyRandomized controlled trialOpen level method

Outcome Measures

Primary Outcomes (1)

Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.
6 month

Secondary Outcomes (3)

Patient and graft survival rates during the 6 and 12 months post-transplant
6 and 12 month
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant
12 month

Study Arms (2)

Prograf-XL + MMF

EXPERIMENTAL

Drug: Prograf-XLDrug: MMF

Prograf + MMF

ACTIVE COMPARATOR

Drug: PrografDrug: MMF

Interventions

Prograf-XLDrug

oral

Also known as: tacrolimus extended release, FK506E, MR4

Prograf-XL + MMF

PrografDrug

oral

Also known as: tacrolimus, FK506

Prograf + MMF

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
Patient is a primary liver transplant recipient

Sponsors & Collaborators

Astellas Pharma Taiwan, Inc.
Industrycollaborator
Astellas Pharma Inc
Industrylead

Study Sites (4)

Kaohsiung City, 833, Taiwan

Taipei, 100, Taiwan

Taipei, 112, Taiwan

Taoyuan, 333, Taiwan

MeSH Terms

Interventions

TacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

Central Contact
Astellas Pharma Inc
STUDY CHAIR

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

December 2007

Date type not reported

This date has not been verified as actual or estimated.

A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Prograf-XL + MMF

Prograf + MMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Prograf-XL + MMF

Prograf + MMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations