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| Sponsor: | FDA Office of Orphan Products Development |
|---|---|
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00029328 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Pneumonia |
Drug: etanercept |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation |
| Estimated Enrollment: | 15 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | September 2003 |
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.
Eligibility| Ages Eligible for Study: | 12 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00029328 History of Changes |
| Other Study ID Numbers: | FD-R-2020-01, UMCC-0078;, FD-R-002020-01 |
| Study First Received: | January 10, 2002 |
| Last Updated: | January 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
TNFR-Fc fusion protein Stem Cell Transplantation Transplantation, Homologous Respiratory Function Tests |
|
Bronchiolitis Bronchiolitis Obliterans Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
Lung Injury TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents |
