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| Sponsored by: |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study |
| 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
| Study ID Numbers: | FD-R-2020-01, UMCC-0078;, FD-R-002020-01 |
| Study First Received: | January 10, 2002 |
| Last Updated: | January 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00029328 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
TNFR-Fc fusion protein Stem Cell Transplantation Transplantation, Homologous Respiratory Function Tests |
|
Anti-Inflammatory Agents Lung Diseases, Interstitial Immunologic Factors Bronchial Diseases Bronchiolitis Respiratory Distress Syndrome, Adult Respiration Disorders Acute Respiratory Distress Syndrome TNFR-Fc fusion protein Immunosuppressive Agents Bronchiolitis Obliterans Necrosis |
Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Analgesics, Non-Narcotic Lung Diseases Anti-Inflammatory Agents, Non-Steroidal Bronchitis Peripheral Nervous System Agents Analgesics Antirheumatic Agents Pneumonia |
|
Anti-Inflammatory Agents Immunologic Factors Bronchial Diseases Respiratory Distress Syndrome, Adult Physiological Effects of Drugs TNFR-Fc fusion protein Bronchiolitis Obliterans Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Sensory System Agents Syndrome Therapeutic Uses Bronchitis |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Lung Diseases, Interstitial Disease Bronchiolitis Respiration Disorders Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Pneumonia |
