Multiple Patient Program for Lamprene (clofazimine) for Treatment of Non-Tuberculosis Mycobacterial (NTM) Infections
Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).
- Male or female patients 18 years of age or older
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Written informed consent must be obtained before any project specific assessment is performed.
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Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection)
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Patients who failed or are intolerant of prior therapies or who have baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised
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Male patients (including vasectomized patients) who agree to use a condom during intercourse while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine
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- History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine
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History or current diagnosis of clinically significant ECG abnormalities that pose a safety risk for the patient, such as clinically significant cardiac arrhythmias (e.g.,sustained ventricular tachycardia, second or third degree heart block without a pacemaker)
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History or additional risk factors for Torsades de Pointes such as heart failure, clinically relevant hypokalemia, familial long QT syndrome or known family history of Torsades de Pointes
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Confirmed demonstration of resting QTcF >500 msec at screening
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Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe
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