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

2014-08-27 03:17:57 | BioPortfolio

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.

Study Design

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

Conditions

Lung Transplantation

Intervention

mycophenolate mofetil [CellCept]

Location

Hannover
Germany
30625

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:57-0400

Clinical Trials [2186 Associated Clinical Trials listed on BioPortfolio]

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups...

Intensified Dosing of Cellcept (Mycophenolate Mofetil) in Kidney Transplantation

The primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured by dr...

A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based t...

A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.

This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. ...

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

This study will assess the efficacy and safety of CellCept(1g or 1.5g po bid for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the stu...

PubMed Articles [6272 Associated PubMed Articles listed on BioPortfolio]

Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression: Erratum.

Autoimmune Ascites Responding to Mycophenolate Mofetil: A Case Report.

Ascites is an abnormal accumulation of fluid within the peritoneal cavity. The most common cause of ascites in the United States population is portal hypertension secondary to cirrhosis, accounting fo...

Immunosuppression following liver transplantation and the course of inflammatory bowel disease - a case control study.

Aim The aim of this study was to investigate the influence of immunosuppression following orthotopic liver transplantation (OLT) on course of inflammatory bowel disease (IBD) including disease activ...

The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D.

The transplant community is divided regarding whether substitution with generic immunosuppressants is appropriate for organ transplant recipients. We estimated the rate of uptake over time of generic ...

Mycophenolate mofetil for induction and maintenance of remission in naïve patients with granulomatosis with polyangiitis without renal involvement.

Antineutrophil cytoplasmic antibodies (ANCA) associated vasculitides include granulomatosis with polyangiitis (GPA, previously called Wegener's), microscopic polyangiitis (MPA) and eosinophilic granul...

Medical and Biotech [MESH] Definitions

Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.

The transference of either one or both of the lungs from one human or animal to another.

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

An organism that, as a result of transplantation of donor tissue or cells, consists of two or more cell lines descended from at least two zygotes. This state may result in the induction of donor-specific TRANSPLANTATION TOLERANCE.

Transplantation between individuals of the same species. Usually refers to genetically disparate individuals in contradistinction to isogeneic transplantation for genetically identical individuals.

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