Chronic Graft vs Host Disease

Chronic Graft-Versus-Host-Disease

Bronchiolitis Obliterans Syndrome

Phase 1b Cycle= 14 days: Each dose level will increase by 60mg PO BID, up to a maximum of 240mg PO BID
Phase 2 Cycle=28 days: MTD PO BID

MPH966

National Institutes of Health Clinical Center, 9000 Rockville Pike

Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

A Phase 1b/2 Study of Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

Efficacy/drug effect on laboratory values.

National Cancer Institute (NCI)

Lung Transplantation

Bronchiolitis Obliterable Syndrome

Alpha -1 Antitrypsin

Alpha-1 Antitrypsin

Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients

Adverse events and concomitant medication recording and follow up. Safety/tolerability parameters at baseline (Day #1) will be compared with values generated at the following visits every 6 weeks (+/- 10 days).
At all visits, AEs and concomitant medications will be recorded. Additionally, the study coordinator will check occurrence of AE and concomitant medications by a telephone visit

Change in lung function FEV%, FEV1, FVC Baseline (Day #1) values of FEV1 and FVC (and FEV%) will be compared to the following visits every 6 weeks (+/- 10 days).
Incidence of Acute cellular rejection. Incidence of respiratory infection leading to antibiotics administration according to the decision of the investigator.

Mordechai Kramer MD

Rabin Medical Center

Children Who Underwent Heart Transplantation Prior to Age 18

Received Care at Children's Healthcare of Atlanta

Children's Healthcare of Atlanta

Allograft Fibrosis Following Pediatric Cardiac Transplantation

Allograft Fibrosis: Its Regulation and Significance Following Pediatric Cardiac Transplantation

bronchiolitis

protease

bronchiolitis/protease

Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients

Allograft Fibrosis Following Pediatric Cardiac Transplantation

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