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Lamprene Multiple Patient Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04334070
Expanded Access Status : Available
First Posted : April 3, 2020
Last Update Posted : February 8, 2024
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date April 2, 2020
First Posted Date April 3, 2020
Last Update Posted Date February 8, 2024
Descriptive Information
Brief Title Lamprene Multiple Patient Program
Brief Summary

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.

Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: MAP requests are initiated by a licensed physician.https:// www.novart 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries Not Provided
Removed Location Countries Canada,   United States
Administrative Information
NCT Number NCT04334070
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Novartis
Verification Date February 2024