- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00029328
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
March 24, 2015 updated by: FDA Office of Orphan Products Development
Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders.
Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT.
One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF).
Etanercept is an experimental drug that attempts to block TNF lung damage.
Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection.
If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection.
There will be weekly blood tests and bronchoscopy after the last drug dose.
Study Type
Interventional
Enrollment
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kenneth Cooke, M.D., University of Michigan, Ann Arbor, MI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
January 10, 2002
First Submitted That Met QC Criteria
January 10, 2002
First Posted (Estimate)
January 11, 2002
Study Record Updates
Last Update Posted (Estimate)
March 25, 2015
Last Update Submitted That Met QC Criteria
March 24, 2015
Last Verified
November 1, 2001
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Lung Injury
- Infant, Premature, Diseases
- Bronchitis
- Pneumonia
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Bronchiolitis
- Bronchiolitis Obliterans
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- FD-R-2020-01
- UMCC-0078;
- FD-R-002020-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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