Lamprene Multiple Patient Program
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
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).
To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.
Eligibility criteria
Qualifiers
Male or female patients 18 years of age or older
Written informed consent must be obtained before any project specific assessment is performed.
Patients previously diagnosed with NTM infection with local or disseminated infection(i.e. patients with any NTM species at any site of infection)
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
Disqualifiers
History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine
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)
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
Confirmed demonstration of resting QTcF >500 msec at screening
Trial design
Treatments tested in this trial
- Lamprene®/Clofazimine
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov