Lamprene Multiple Patient Program
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|ClinicalTrials.gov Identifier: NCT04334070|
Expanded Access Status : Available
First Posted : April 3, 2020
Last Update Posted : November 30, 2020
|First Submitted Date||April 2, 2020|
|First Posted Date||April 3, 2020|
|Last Update Posted Date||November 30, 2020|
|Brief Title||Lamprene Multiple Patient Program|
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|
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||Canada, United States|
|Removed Location Countries|
|Responsible Party||Novartis ( Novartis Pharmaceuticals )|
|Study Sponsor||Novartis Pharmaceuticals|
|Verification Date||November 2020|