Status:
COMPLETED
Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Idiopathic Pulmonary Fibrosis
Diffuse Parenchymal Lung Disease
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in lung function and premature death from respiratory failure. Fibrocytes are a novel population of bone marrow-d...
Eligibility Criteria
Inclusion
- Male and female patients 21-85 years of age
- Individuals diagnosed with IPF, based on:
- clinical symptoms consistent with idiopathic pulmonary fibrosis (IPF) of \> 3 months duration, plus
- histologically diagnosed UIP or diagnostic chest high resolution CT features of UIP, plus
- negative workup for known causes of UIP
- Ability to understand a written informed consent form and comply with the requirements of the study.
Exclusion
- Clinical features or known diagnosis of an active infection, including untreated latent tuberculosis
- Clinical features or known diagnosis of malignancy
- Known diagnosis of an interstitial lung disease other than IPF including but not limited to sarcoidosis, hypersensitivity pneumonitis, non-specific interstitial pneumonia (NSIP).
- History of clinically significant environmental exposures known to cause interstitial lung disease (including but not limited to drugs, asbestos, silica, beryllium, radiation, domestic birds, etc).
- Diagnosis of any connective tissue disease (including but not limited to scleroderma, SLE, rheumatoid arthritis) or vasculitides according to the American College of Rheumatology criteria.
- Systolic blood pressure \< 100 or \>145 mm Hg or diastolic blood pressure \< 50 or \>90 mmHg
- Evidence of active infection within 1 week prior to enrollment.
- Recently started (\<8 weeks prior to baseline visit) or planned cardiopulmonary rehabilitation program before conclusion of the study
- History of unstable or deteriorating cardiac disease, including but not limited to: myocardial infarction, coronary artery bypass surgery or angioplasty within the past 6 months, congestive heart failure requiring hospitalization within the past 6 months, or uncontrolled arrhythmia
- History of unstable or deteriorating neurologic disease, including but not limited to: TIAs or stroke
- Pregnant or lactating females. Females of child bearing potential are required to have a negative serum or urine pregnancy test prior to treatment and agree to practice abstinence or prevent pregnancy by at least a barrier method of birth control.
- Liver panel above specific limits at screening: Total bilirubin \>1.5-fold upper limit of normal, AST, ALT or alkaline phosphatase \> 3-fold upper limit of normal at screening.
- Hematology outside of specified limits, WBC \<2,500/ mm3, hematocrit \<30, platelets \<100,000/mm3 at screening.
- Investigational therapy for any indication within 28 days prior to treatment.
- Current treatment with drugs that are strong inhibitors of CYP3A4 or P-gp, namely bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, HIV-protease inhibitors (e.g., ritonavir, indinavir), metoclopramide, nicardipine, troleandomycin, verapamil
- Inability or unwillingness to comply with the requirements for the trial.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01462006
Start Date
October 1 2011
End Date
March 1 2016
Last Update
March 22 2021
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610