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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT00029328 |
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Date of registration:
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10/01/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
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Scientific title:
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Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation |
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Date of first enrolment:
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September 2001 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00029328 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Cooke, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan, Ann Arbor, MI |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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
Exclusion criteria:
- 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
Age minimum:
12 Months
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumonia
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Bronchiolitis Obliterans
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Respiratory Distress Syndrome, Adult
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Intervention(s)
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Drug: etanercept
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Secondary ID(s)
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FD-R-2020-01
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FD-R-002020-01
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UMCC-0078;
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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