Lamprene Multiple Patient Program

Investigation of an Investigational Medication for Drug-Resistant Mycobacterial Infections

T
Tom F. Hrisomalos, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
1 Location

Brief description of study

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 inhe US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosisd non-tuberculous mycobacteria (NTM).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - 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 accessgram. 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, thisy be because the patient has a type of Mycobacterial infection that is resistant or failedd optimally to other drugs, or because the patient has had side effects that preventhe use of other drugs. The physician must submit a patient registration form to initiate the eval process.

Detailed description of study

Drug: Lamprene®/Clofazimine
  • All participants will receive Lamprene/clofazimine 50 mg capsules. The recommended dose of clofazimine for this program is 100 mg once daily, administered orally, preferably with meals. Duration of treatment will be decided by the treating physician. When considering clofazimine for the treatment of NTM infection, clofazimine is to be administered as part of a multi-drug regimen.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Tuberculous Mycobacterial (NTM) Infections
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:
  1. Male or female patients 18 years of age or older
  2. Written informed consent must be obtained before any project specific assessment isd.
  3. Patients previously diagnosed with NTM infection with local or disseminated(i.e. patients with any NTM species at any site of infection)
  4. Patients who failed or are intolerant of prior therapies or who have baselinede resistance or for whom an appropriate regimen cannot otherwise be devised
  5. Male patients (including vasectomized patients) who agree to use a condom duringurse while taking clofazimine treatment and for at least 4 months afterg treatment with clofazimine
  6. Female patients of child-bearing potential with negative pregnancy test beforezimine treatment initiation and who confirm no intention to become pregnantduring the treatment with clofazimine, by using highly effective methods of(methods that result in less than 1% pregnancy rates) while takingzimine treatment and for at least 4 months after stopping treatment withzimine
Exclusion Criteria:
  1. History of hypersensitivity to any drugs or metabolites of similar chemical classes aszimine
  2. History or current diagnosis of clinically significant ECG abnormalities that pose ay risk for the patient, such as clinically significant cardiac arrhythmias(e.g.,sustained ventricular tachycardia, second or third degree heart block without aker)
  3. History or additional risk factors for Torsades de Pointes such as heart failure,y relevant hypokalemia, familial long QT syndrome or known family history ofTorsades de Pointes
  4. Confirmed demonstration of resting QTcF >500 msec at screening
  5. Any condition (social, psychiatric, or medical) which in the opinion of the treatinghysician would make participation in this MPP unsafe
  6. Unable to swallow capsules
  7. HIV-infected patients with disseminated NTM infection
  8. Life expectancy less than 6 months
  9. Pregnant or nursing (lactating) females

Updated on 20 Aug 2025. Study ID: CLAM320B2002M, ECRO-NOVARTIS-CLAM320B2002M, 15553

This study investigates the use of clofazimine, an investigational medication, for patients with drug-resistant non-tuberculous mycobacteria (NTM) infections. NTM infections occur when bacteria from the environment cause illness in people. Clofazimine is usually used to treat leprosy but is being tested here for its effectiveness against NTM, especially in cases where other treatments have failed or cannot be used.

Participants in this study will receive clofazimine capsules, taken orally, as part of a multi-drug regimen. The dosage is 100 mg once daily, preferably with meals. The treatment duration will be determined by the treating physician. This study involves providing the medication through an expanded access program, which allows the use of clofazimine in special cases where no other treatment options are available.

  • Who can participate: Adults aged 18 and over with a confirmed diagnosis of NTM infection can participate. Eligibility requires failure or intolerance to prior therapies or resistance to available treatments.
  • Study details: Participants will take the investigational medication daily as part of a multi-drug regimen. It is provided through an expanded access program, meaning it is used under special conditions when other treatments aren't suitable.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only