Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)

This study is currently recruiting participants.
Verified January 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01462006
First received: October 26, 2011
Last updated: January 14, 2013
Last verified: January 2013

October 26, 2011
January 14, 2013
October 2011
November 2015   (final data collection date for primary outcome measure)
  • fibrocytes [ Time Frame: up to 22 weeks ] [ Designated as safety issue: No ]
    change in peripheral blood concentration of CXCR4+ fibrocytes
  • number of subjects with drug side-effects [ Time Frame: up to 22 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01462006 on ClinicalTrials.gov Archive Site
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Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)
Double-blind Placebo-controlled Pilot Study of Sirolimus in IPF

Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in lung function and premature death from respiratory failure. There is currently no effective therapy for this disease. Fibrocytes are a novel population of bone marrow-derived circulating progenitor cells that have been shown to traffic to the lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and whose numbers correlate with the degree of fibrosis and with survival in human pulmonary fibrosis. The investigators propose to test the hypothesis that therapy with the mTOR inhibitor, sirolimus, reduces the number of circulating fibrocytes in patients with IPF. The investigators propose to test this hypothesis in short-term pilot trial of sirolimus in patients with IPF to determine its effect on the number and phenotype of circulating fibrocytes.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Idiopathic Pulmonary Fibrosis
  • Diffuse Parenchymal Lung Disease
  • Interstitial Lung Disease
  • Drug: sirolimus
    randomized to drug or placebo, followed by washout, followed by crossover
  • Other: Placebo
    randomized to drug or placebo, followed by washout, followed by crossover
  • Experimental: Sirolimus
    Intervention: Drug: sirolimus
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
November 2015
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female patients 21-85 years of age
  2. 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
  3. Ability to understand a written informed consent form and comply with the requirements of the study.

Exclusion Criteria:

  1. Clinical features or known diagnosis of an active infection, including untreated latent tuberculosis
  2. Clinical features or known diagnosis of malignancy
  3. Known diagnosis of an interstitial lung disease other than IPF including but not limited to sarcoidosis, hypersensitivity pneumonitis, non-specific interstitial pneumonia (NSIP).
  4. 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).
  5. 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.
  6. Systolic blood pressure < 100 or >145 mm Hg or diastolic blood pressure < 50 or >90 mmHg
  7. Evidence of active infection within 1 week prior to enrollment.
  8. Recently started (<8 weeks prior to baseline visit) or planned cardiopulmonary rehabilitation program before conclusion of the study
  9. 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
  10. History of unstable or deteriorating neurologic disease, including but not limited to: TIAs or stroke
  11. 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.
  12. 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.
  13. Hematology outside of specified limits, WBC <2,500/ mm3, hematocrit <30, platelets <100,000/mm3 at screening.
  14. Investigational therapy for any indication within 28 days prior to treatment.
  15. Drugs used for therapy of IPF including azathioprine, colchicine, cyclophosphamide, interferon gamma1b, mycophenolate mofetil, cyclosporin, D-penicillamine, methotrexate, or prednisone at a dose of ≥15mg/day within 28 days prior to enrollment.
  16. 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
  17. Inability or unwillingness to comply with the requirements for the trial.
Both
21 Years to 85 Years
No
Contact: Hong Zhu, RN 434-243-7364 hz3d@virginia.edu
Contact: Borna Mehrad, MD 434-243-4845 Mehrad@virginia.edu
United States
 
NCT01462006
15282, R01HL098329
Yes
University of Virginia
University of Virginia
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Borna Mehrad, MD University of Virginia
University of Virginia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP