Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

Completed · Phase 1/Phase 2

Conditions studied: Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans, Pneumonia

In brief

The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Key facts

Study ID

NCT00029328

Run by

FDA Office of Orphan Products Development

People needed

15

Starts

2001-09-01

Expected to finish

2003-09-01

Last updated by the study team

2015-03-25

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
• At least 1 year of age for IPS stratum
• At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
• At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
• Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

You may not qualify if…

• Documented evidence of active systemic or pulmonary infection
• Cardiogenic failure as cause of pulmonary dysfunction
• Known hypersensitivity to etanercept
• Currently receiving dialysis
• Currently receiving inotropic medications except dopamine
• Pregnant or nursing

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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