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Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells

NCT00777400 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-05-14

No results posted yet for this study

Summary

The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.

Conditions

Interventions

DRUG

Efalizumab

1 mg/kg of efalizumab administered sub q once weekly

Sponsors & Collaborators

Principal Investigators

  • Flavio Vincenti, M.D. · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777400 on ClinicalTrials.gov