Status:
COMPLETED
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
Lead Sponsor:
Actelion
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to de...
Detailed Description
The study included two treatment periods: Period 1 (fixed duration) from randomization up to the primary endpoint evaluation (Month 12 or earlier in case of premature discontinuation of study drug) an...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception).
- IPF diagnosis within 3 years prior to randomization, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy.
Exclusion
- Interstitial lung disease due to conditions other than IPF.
- Presence of extensive honeycombing on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization.
- Severe concomitant illness limiting life expectancy (\< 1 year).
- Severe restrictive lung disease: forced vital capacity (FVC) \< 50% predicted, or FVC \< 1.2 liter.
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 30% predicted.
- Residual volume ≥ 120% predicted.
- Obstructive lung disease: forced expiratory volume in 1 second (FEV1)/FVC) \< 0.70.
- Documented sustained improvement of the patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
- Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
- Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests).
- Chronic heart failure with New York Heart Association class III/IV or known left ventricular ejection fraction \< 25%.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- Estimated creatinine clearance \< 30 mL/min.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase \> 1.5 x upper limit of normal.
- Hemoglobin \< 75% of the lower limit of the normal range.
- Systolic blood pressure \< 100 mmHg.
- Pregnant or breast-feeding.
- Current drug or alcohol dependence.
- Chronic treatment with the following drugs (within 4 weeks of randomization):
- Oral corticosteroids (\> 20 mg/day of prednisone or equivalent),
- Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine,
- Antifibrotic drugs including pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib and interferon γ,
- Chronic use of N-acetylcysteine prescribed for IPF (\> 600 mg/day).
- Oral anticoagulants prescribed for IPF.
- Treatment with endothelin receptor antagonists within 4 weeks prior to randomization.
- Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
- Treatment with Cytochrome P450 3A inducers within 4 weeks prior to randomization.
- Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- Planned treatment, or treatment with another investigational drug within 4 weeks prior to randomization.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00903331
Start Date
May 1 2009
End Date
August 1 2011
Last Update
February 17 2014
Active Locations (53)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Pulmonary Associates, P.A.
Phoenix, Arizona, United States, 85006
3
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
4
U.C. Davis University of California
Sacramento, California, United States, 95817