Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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 demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

Key facts

Study ID

NCT00903331

Run by

Actelion

People needed

178

Starts

2009-05-01

Expected to finish

2011-08-01

Last updated by the study team

2014-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, P.A. — Phoenix, Arizona, United States
• Mayo Clinic - Arizona — Scottsdale, Arizona, United States
• U.C. Davis University of California — Sacramento, California, United States
• UCSD Pulmonary Critical Care — San Diego, California, United States
• University of California - San Francisco — San Francisco, California, United States
• Stanford University Medical Center - Chest Clinic — Stanford, California, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Wichita Clinic P.A — Wichita, Kansas, United States
• St. Luke's Medical Group — Chesterfield, Missouri, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Temple University Hospital - Lung Center — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine - Baylor Clinic — Houston, Texas, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Prince Charles Hospital Lung Transplant — Chermside, Australia
• St. Vincent's Public Hospital — Darlinghurst, Australia
• The Alfred Hospital — Melbourne, Australia
• Royal Perth Hospital — Perth, Australia
• University of Alberta - Health Sciences Center — Edmonton, Alberta, Canada
• Kelowna General Hospital — Kelowna, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• St. Joseph's Healthcare — Hamilton, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Hospital Notre-Dame du CHUM — Montreal, Quebec, Canada
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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