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Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) Clinical research trials and Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF). Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) clinical trial. Participants typically obtain the most effective healthcare available for their Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)  Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
For Condition: Idiopathic Pulmonary Fibrosis,Pulmonary Fibrosis
Status: Recruiting
Sponsor(s): InterMune ,
Synopsis: To assess the long-term safety and efficacy of oral pirfenidone in doses of 40 mg/kg/d for up to 152 weeks in a limited number of patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF) - Enrollment: A limited number of patients will be enrolled from up to 20 centers; - Duration: 3 years
Details: This study has been designed as a rollover study to collectively include safety and efficacy data from various previous studies. In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. Patients with documented IPF may register to be included in the program’s computerized random selection process provided they meet the initial criteria. On behalf of InterMune, the National Organization for Rare Disorders (NORD) is independently conducting the patient registration and selection of this program. Only patients who are randomly selected by NORD will be eligible to enter the limited Early Access Program. Selected patients who meet eligibility criteria will receive pirfenidone via their physician until the drug has been approved for marketing by the FDA and is commercially available or until the program is terminated by InterMune. This program is also being conducted under this protocol.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/85 Years
Genders: Both
Protocol Entry Criteria: Roll-Over Criteria: - Previous participation in InterMune protocol PIPF-001 and completed 24 months of treatment or completed the study; - Previous participation in previous sponsor’s individual patient protocol for pirfenidone use in patients with PF or IPF; - Previous participation or commitment by InterMune to participate in a Pirfenidone investigator-sponsored IND for the treatment of IPF; Criteria for Early Access Program patients: - Clinical symptoms consistent with IPF 3 months duration; - Diagnosis of IPF, defined as first instance in which a patient was informed of having pulmonary fibrosis, within 48 months of randomization; - Age 40 – 85, inclusive; - High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient; - For patients aged < 50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP, in the absence of any features supporting an alternate diagnosis, within 48 months of randomization; - For patients aged 50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months of randomization: - Open or VATS lung biopsy showing definite or probable UIP - Transbronchial biopsy showing no features to support an alternative diagnosis - Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis.
Total Enrollment:
Location and Contact Information:
InterMune, Inc. *Recruiting*
Brisbane, California, 94005
United States
Recruiting
Additional Information:
Study ID Numbers: PIPF-002;
Study Start Date: August 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080223
Other Idiopathic Pulmonary Fibrosis Studies:
1. Specimen Collection for Individuals with Lung Disease Associated with Rheumatoid Arthritis
2. An Open-Label Study of the Safety of Interferon gamma-1b in Patients with IPF
3. Identification of Genes Associated with Lung Disease in Patients with Rheumatoid Arthritis
4. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
5. Segmental Bronchoalveolar Lavage
Related Studies:
Other Idiopathic Pulmonary Fibrosis Clinical Trials
Other California Clinical Trials
Other Brisbane Clinical Trials
Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
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