Expired Study
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New York, New York 10016


Purpose:

A Safety and Efficacy trial of aerosol Interferon-gamma treatment in Pulmonary Fibrosis


Criteria:

Inclusion Criteria: - Patients diagnosed with IPF based on accepted criteria within 30 months prior to screening - Age 20-70 - A failed trial of prednisone with or without cyclophosphamide/ azathioprine - Patient taking 0-15mg prednisone or the equivalent for 28 days prior to study enrollment and willing to remain on that same dose of corticosteroid - FVC >= 50% and <= 90% of predicted baseline value at screening - PaO2 > 60 mm Hg at rest on room air - Patient able to understand and willing to sign a written informed consent and willing to comply with all requirements of the study protocol including: - Patient fits criteria for research bronchoscopy and is willing to undergo procedure - Patient able to have medication administered three times per week at the GCRC unit at Bellevue Hospital Exclusion Criteria: - No adequate treatment trial with prednisone, cyclophosphamide, or azathioprine - patient unwilling or unable to undergo research bronchoscopy - Patient with known asthma or severe COPD - Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation - Patient with hypersensitivity to study medication or other component medication - Patient with known severe cardiac disease, severe peripheral vascular disease or seizure disorder which may be exacerbated by study drug administration (contraindications to drug administration as per package insert). - Pregnant or lactating. Females of child-bearing age will be required to have negative pregnancy test and be required to use accepted form of birth control (abstinence for study duration is the preferred method). - Evidence of active infection within one week prior to treatment - Any condition, other than IPF, which is likely to result in the death of the patient within one year from study enrollment - Abnormal serum laboratory values including: 1. Liver function above specified limits: total bilirubin > 1.5 X upper limits of normal, alanine amino transferase > 3X upper limit of normal, alkaline phosphatase < 3X upper limit of normal, albumin < 3.0 at screening. 2. CBC outside specified limits: WBC < 2,500/mm3, hematocrit <30 or >59, platelets < 100,000/mm3. 3. Creatinine > 1.5X upper limits normal at screening - Drugs for therapy for pulmonary fibrosis, excluding corticosteroids/cyclophosphamide/azathioprine, within the previous six months - Prior therapy with any class of interferon medication - Investigational therapy for any indication within the last 28 days


NCT ID:

NCT00212563


Primary Contact:

Principal Investigator
Rany Condos, MD
NYU School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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