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Idiopathic Pulmonary Fibrosis Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Idiopathic Pulmonary Fibrosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Idiopathic Pulmonary Fibrosis Clinical research trials and Idiopathic Pulmonary Fibrosis healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Idiopathic Pulmonary Fibrosis. Idiopathic Pulmonary Fibrosis Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Idiopathic Pulmonary Fibrosis clinical trial. Human subjects often obtain the finest healthcare possible for their Idiopathic Pulmonary Fibrosis condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Idiopathic Pulmonary Fibrosis  Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
For Condition: Pulmonary Fibrosis
Status: Recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Diagnosis of IPF based on American Thoracic Society (ATS) guidelines. - Subjects who have progressed within 24 months of screening despite standard of care. Progression is defined as worsened dyspnea and at least one of the following criteria - Forced vital capacity (FVC) not improved by 10% - Carbon monoxide diffusing capacity of the lung (DLCO) not improved by 15% - Worsened oxygenation by 10% with or without exertion or, - Worsened chest x-ray Standard of care may include drug therapy, antibiotics, oxygen, pulmonary rehabilitation, or no therapy, all at the discretion of the physician according to ATS guidelines. - Between 40 and 80 years of age. - Negative result of serum ß-human chorionic gonadotropin (ß –HCG) pregnancy test taken at screening for all women except those surgically sterile or at least 1 year postmenopausal. - Willingness of male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study. - Subject should be able to reconstitute and self-inject test article or have a designee who can do so. - Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed. - Subjects must be able to store injectable test article at 2˚C to 8˚C (36˚F to 46˚F). Exclusion Criteria: - Subjects with end-stage IPF defined by presence of any one of the following: - FVC < 45% predicted or, - Carbon monoxide diffusing capacity of the lung corrected for hemoglobin (DLCOc) < 25% predicted or, - Partial arterial pressure of oxygen (PaO2) < 55 mm Hg (room air) and oxygen saturation < 88% (room air) at rest. - Any concomitant treatment for IPF with corticosteroids (systemic or orally inhaled), azathioprine, cyclophosphamide, or other medications used specifically to treat IPF such as colchicine, pirfenidone, D-penicillamine, interferon gamma (IFN-γ) and interferon beta (IFN-β). - Receipt of corticosteroids (systemic or orally inhaled), azathioprine, cyclophosphamide or other medication used specifically to treat IPF such as colchicine, pirfenidone, D-penicillamine, IFN-γ, and IFN-β within 4 weeks of baseline. - Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor). - Receipt of any investigational drug or biological agent within 4 weeks of screening visit. - Abnormality in blood chemistry or hematology profiles: hemoglobin 85 g/L (5.2751 mmol/L); hematocrit 27%; white blood cell count 3.5 x 10^9/L; platelet count 125 x 10^9 /L; serum creatinine 175 μmol/L; aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase[SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) 2 times the laboratory’s upper limit of normal; or other clinically important laboratory abnormalities. - Important concurrent medical events including - Concurrent severe chronic obstructive pulmonary disease (COPD), defined as residual volume (RV) > 120% predicted or forced expiratory volume in 1 second (FEV1/FVC) < 0.65 - Clinically significant asthma - Presence of active infection including human immunodeficiency virus (HIV) or any underlying diseases that could predispose subjects to infections. - Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 180 mm Hg or screening diastolic blood pressure of greater than 110 mm Hg). - Myocardial infarction within 12 months of the screening visit - Unstable angina pectoris. - Uncompensated congestive heart failure. - Diagnosis of multiple sclerosis or other central demyelinating diseases. - Presence or history of confirmed blood dyscrasias - Insulin-dependent diabetes mellitus. - Any rheumatological disease such as rheumatoid arthritis, systemic vasculitis, systemic lupus erythematous, scleroderma, or polymyositis. - Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma) - Open cutaneous ulcers - Presence of hepatitis B surface antigen (HBsAg) (at screening visit only) - Presence of antibody to hepatitis C virus (anti-HCV) as confirmed by hepatitis C recombinant immunoblot assay (HCV – RIBA) (at screening visit only) - Any condition that, in the physician’s judgment, might cause this study to be detrimental to the subject - Pregnant or breast-feeding women - History of poor compliance - History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent - History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
Total Enrollment:
Location and Contact Information:
Hospital of University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Milton Rossman 215-573-9890
University of Virginia Health System *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting George Verghese 434-924-5210
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Mark Steele 919-684-6140
The University of Texas Southwestern Medical Center at Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Yolanda Mageto 214-648-2195
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jim Utz 507-284-2511
Uniklinik Muenchen Grosshadern *Recruiting*
Muenchen, , 81366
Germany
Recruiting PD Juergen Behr 49-89-7095-3071
Highland Hospital *Recruiting*
Rochester, New York, 14620
United States
Recruiting Michael Kallay 585-341-6774
The University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Imre Noth 773-834-1832
Ruhrlandklinik Essen *Recruiting*
ESSEN, , 45239
Germany
Recruiting Prof. Costabel +49 (0) 201 433 4021
University of Wisconsin *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Keith Meyer 608-263-3035
UZ Gasthuisberg *Recruiting*
Leuven, , 3000
Belgium
Recruiting Dr. Thomeer 32-16-346-800
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Joseph Lasky 504-588-2250
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Lisa Lancaster 615-343-7068
University of Washington Medical Center *Recruiting*
Seattle, Washington, 98195
United States
Recruiting Ganesh Raghu 206-598-4697
Hopital Louis Pradel *Recruiting*
Lyon Cedex 03, , 69394
France
Recruiting Prof Cordier 33-4-72-35-72-69
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Jeffrey Chapman 216-444-4222
VA Medical Center *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Rafael Perez 404-321-6111
INOVA Fairfax Hospital *Recruiting*
Falls Church, Virginia, 22042
United States
Recruiting Steven Nathan 703-698-3610
National Jewish Center *Recruiting*
Denver, Colorado, 80206
United States
Recruiting Kevin Brown 303-398-1621
University of Cincinnati Medical Center *Recruiting*
Cincinnati, Ohio, 45267
United States
Recruiting Robert Baughman 513-584-5223
Additional Information:
Study ID Numbers: 0881A4-203-WW;
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063869
Other Pulmonary Fibrosis Studies:
1. A Randomized, Double-Blind, Three-arm, Phase 3b Study Comparing the Safety and efficacy of Interferon gamma-1b with Azatioprine, and Azathioprine Alone in Patients with IPF Receiving Prednisone
2. Clinical and Basic Investigations into Hermansky-Pudlak Syndrome
3. Idiopathic Pulmonary Fibrosis: a Case-control Study
4. Identification of Genes Associated with Lung Disease in Patients with Rheumatoid Arthritis
5. Idiopathic Pulmonary Fibrosis
Related Studies:
Other Pulmonary Fibrosis Clinical Trials
Other Clinical Trials
Other Lyon Cedex 03 Clinical Trials
Idiopathic Pulmonary Fibrosis
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