A Study of CellCept (Mycophenolate Mofetil) in Lung Transplant Recipients

Status Completed

Clinical Trial Summary

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of Cellcept in lung allograft recipients. Patients will be split into 2 groups according to the original disease: group A (cystic fibrosis) and group B (chronic obstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency). All patients will receive CellCept orally, 1.5g twice daily on days 1-30 post transplantation, and 1g twice daily on days 31-90. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Lung Transplantation

Clinical Trial Details

NCT number	NCT01014442
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Completed
Phase	Phase 3
Start date	January 2010
Completion date	June 2012

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