Lamprene Multiple Patient Program

December 1, 2025 updated by: Novartis Pharmaceuticals

Novartis Multiple Patient Program for Lamprene® (Clofazimine) for the Treatment of Non-Tuberculous 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).

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.

Study Overview

Status

Available

Conditions

Non-Tuberculous Mycobacterial (NTM) Infections

Intervention / Treatment

Drug: Lamprene®/Clofazimine

Study Type

Expanded Access

Expanded Access Type

Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T1Y 6J4
    - Available
    - Novartis Investigative Site
- Ontario
  - Toronto, Ontario, Canada, M5G 1X8
    - Available
    - Novartis Investigative Site
  - Toronto, Ontario, Canada, M5T 2S8
    - Available
    - Novartis Investigative Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Available
    - Novartis Investigative Site
  - Birmingham, Alabama, United States, 35233-1711
    - Available
    - Novartis Investigative Site
  - Birmingham, Alabama, United States, 35294-0006
    - Available
    - Novartis Investigative Site
  - Birmingham, Alabama, United States, 35294
    - Available
    - Novartis Investigative Site
  - Mobile, Alabama, United States, 36608-1128
    - Available
    - Novartis Investigative Site
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Available
    - Novartis Investigative Site
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Available
    - Novartis Investigative Site
  - Phoenix, Arizona, United States, 85013
    - Available
    - Novartis Investigative Site
  - Phoenix, Arizona, United States, 85032
    - Available
    - Novartis Investigative Site
  - Phoenix, Arizona, United States, 85054
    - Available
    - Novartis Investigative Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Available
    - Novartis Investigative Site
- California
  - Bellflower, California, United States, 90706
    - Available
    - Novartis Investigative Site
  - Duarte, California, United States, 91010
    - Available
    - Novartis Investigative Site
  - Fontana, California, United States, 92335
    - Available
    - Novartis Investigative Site
  - Loma Linda, California, United States, 92354
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90005-1752
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90017
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90033-4605
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90033
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90036
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90048
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90073
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90095-1752
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90095-1793
    - Available
    - Novartis Investigative Site
  - Los Angeles, California, United States, 90095
    - Available
    - Novartis Investigative Site
  - Palo Alto, California, United States, 94304
    - Available
    - Novartis Investigative Site
  - Panorama City, California, United States, 91402
    - Available
    - Novartis Investigative Site
  - Pasadena, California, United States, 91105
    - Available
    - Novartis Investigative Site
  - San Diego, California, United States, 92103
    - Available
    - Novartis Investigative Site
  - San Diego, California, United States, 92134
    - Available
    - Novartis Investigative Site
  - San Francisco, California, United States, 94143
    - Available
    - Novartis Investigative Site
  - San Jose, California, United States, 95119 1130
    - Available
    - Novartis Investigative Site
  - San Luis Obispo, California, United States, 93401
    - Available
    - Novartis Investigative Site
  - Santa Barbara, California, United States, 93105
    - Available
    - Novartis Investigative Site
  - Santa Monica, California, United States, 90404
    - Available
    - Novartis Investigative Site
  - Stanford, California, United States, 94305
    - Available
    - Novartis Investigative Site
  - Torrance, California, United States, 90509
    - Available
    - Novartis Investigative Site
  - Travis Air Force Base, California, United States, 94535
    - Available
    - Novartis Investigative Site
  - Walnut Creek, California, United States, 94598
    - Available
    - Novartis Investigative Site
- Colorado
  - Denver, Colorado, United States, 80205
    - Available
    - Novartis Investigative Site
  - Denver, Colorado, United States, 80206
    - Available
    - Novartis Investigative Site
  - Denver, Colorado, United States, 80218
    - Available
    - Novartis Investigative Site
  - Fort Collins, Colorado, United States, 80526
    - Available
    - Novartis Investigative Site
  - Wheat Ridge, Colorado, United States, 80033
    - Available
    - Novartis Investigative Site
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Available
    - Novartis Investigative Site
  - Waterbury, Connecticut, United States, 06708
    - Available
    - Novartis Investigative Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Available
    - Novartis Investigative Site
  - Newark, Delaware, United States, 19718
    - Available
    - Novartis Investigative Site
  - Wilmington, Delaware, United States, 19718
    - Available
    - Novartis Investigative Site
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Available
    - Novartis Investigative Site
  - Washington, District of Columbia, United States, 20016
    - Available
    - Novartis Investigative Site
  - Washington, District of Columbia, United States, 20057
    - Available
    - Novartis Investigative Site
  - Washington, District of Columbia, United States, 20307-0003
    - Available
    - Novartis Investigative Site
- Florida
  - Aventura, Florida, United States, 33180
    - Available
    - Novartis Investigative Site
  - Delray Beach, Florida, United States, 33445
    - Available
    - Novartis Investigative Site
  - Fort Lauderdale, Florida, United States, 33308
    - Available
    - Novartis Investigative Site
  - Fort Myers, Florida, United States, 33908
    - Available
    - Novartis Investigative Site
  - Gainesville, Florida, United States, 32610
    - Available
    - Novartis Investigative Site
  - Hollywood, Florida, United States, 33021
    - Available
    - Novartis Investigative Site
  - Jacksonville, Florida, United States, 32207
    - Available
    - Novartis Investigative Site
  - Jacksonville, Florida, United States, 32224
    - Available
    - Novartis Investigative Site
  - Kissimmee, Florida, United States, 34741
    - Available
    - Novartis Investigative Site
  - Leesburg, Florida, United States, 34748
    - Available
    - Novartis Investigative Site
  - Miami, Florida, United States, 33136
    - Available
    - Novartis Investigative Site
  - Miami, Florida, United States, 33173
    - Available
    - Novartis Investigative Site
  - Miami Beach, Florida, United States, 33140
    - Available
    - Novartis Investigative Site
  - Naples, Florida, United States, 34102
    - Available
    - Novartis Investigative Site
  - Orlando, Florida, United States, 32803
    - Available
    - Novartis Investigative Site
  - Orlando, Florida, United States, 32804
    - Available
    - Novartis Investigative Site
  - Orlando, Florida, United States, 32806
    - Available
    - Novartis Investigative Site
  - Sarasota, Florida, United States, 34239
    - Available
    - Novartis Investigative Site
  - South Miami, Florida, United States, 33143
    - Available
    - Novartis Investigative Site
  - Tampa, Florida, United States, 33606
    - Available
    - Novartis Investigative Site
  - Tampa, Florida, United States, 33612
    - Available
    - Novartis Investigative Site
  - Tampa, Florida, United States, 33614
    - Available
    - Novartis Investigative Site
  - Weston, Florida, United States, 33331
    - Available
    - Novartis Investigative Site
  - Winter Park, Florida, United States, 32792
    - Available
    - Novartis Investigative Site
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Available
    - Novartis Investigative Site
  - Atlanta, Georgia, United States, 30322
    - Available
    - Novartis Investigative Site
  - Atlanta, Georgia, United States, 30342
    - Available
    - Novartis Investigative Site
  - Augusta, Georgia, United States, 30912
    - Available
    - Novartis Investigative Site
  - Decatur, Georgia, United States, 30033
    - Available
    - Novartis Investigative Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Available
    - Novartis Investigative Site
  - Honolulu, Hawaii, United States, 96814
    - Available
    - Novartis Investigative Site
  - Lihue, Hawaii, United States, 96766
    - Available
    - Novartis Investigative Site
- Idaho
  - Boise, Idaho, United States, 83712
    - Available
    - Novartis Investigative Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Available
    - Novartis Investigative Site
  - Chicago, Illinois, United States, 60616
    - Available
    - Novartis Investigative Site
  - Chicago, Illinois, United States, 60637
    - Available
    - Novartis Investigative Site
  - Peoria, Illinois, United States, 61637
    - Available
    - Novartis Investigative Site
  - Springfield, Illinois, United States, 62703
    - Available
    - Novartis Investigative Site
  - Urbana, Illinois, United States, 61801
    - Available
    - Novartis Investigative Site
- Indiana
  - Indianapolis, Indiana, United States, 46202-5111
    - Available
    - Novartis Investigative Site
  - Indianapolis, Indiana, United States, 46202
    - Available
    - Novartis Investigative Site
- Iowa
  - Clive, Iowa, United States, 50325
    - Available
    - Novartis Investigative Site
  - Iowa City, Iowa, United States, 52242
    - Available
    - Novartis Investigative Site
- Kansas
  - Fairway, Kansas, United States, 66205
    - Available
    - Novartis Investigative Site
  - Kansas City, Kansas, United States, 66160-7820
    - Available
    - Novartis Investigative Site
  - Kansas City, Kansas, United States, 66160
    - Available
    - Novartis Investigative Site
  - Westwood, Kansas, United States, 66205
    - Available
    - Novartis Investigative Site
  - Wichita, Kansas, United States, 67230
    - Available
    - Novartis Investigative Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Available
    - Novartis Investigative Site
  - Lexington, Kentucky, United States, 40511
    - Available
    - Novartis Investigative Site
  - Lexington, Kentucky, United States, 40536
    - Available
    - Novartis Investigative Site
  - Paducah, Kentucky, United States, 42001
    - Available
    - Novartis Investigative Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Available
    - Novartis Investigative Site
  - Baton Rouge, Louisiana, United States, 70809
    - Available
    - Novartis Investigative Site
  - New Orleans, Louisiana, United States, 70112-1328
    - Available
    - Novartis Investigative Site
  - New Orleans, Louisiana, United States, 70112-2699
    - Available
    - Novartis Investigative Site
  - New Orleans, Louisiana, United States, 70112
    - Available
    - Novartis Investigative Site
  - New Orleans, Louisiana, United States, 70115
    - Available
    - Novartis Investigative Site
  - New Orleans, Louisiana, United States, 70121
    - Available
    - Novartis Investigative Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Available
    - Novartis Investigative Site
  - Baltimore, Maryland, United States, 21204
    - Available
    - Novartis Investigative Site
  - Baltimore, Maryland, United States, 21224
    - Available
    - Novartis Investigative Site
  - Baltimore, Maryland, United States, 21287
    - Available
    - Novartis Investigative Site
  - Bethesda, Maryland, United States, 20892
    - Available
    - Novartis Investigative Site
  - Columbia, Maryland, United States, 21045
    - Available
    - Novartis Investigative Site
  - Largo, Maryland, United States, 20774
    - Available
    - Novartis Investigative Site
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Available
    - Novartis Investigative Site
  - Boston, Massachusetts, United States, 02114
    - Available
    - Novartis Investigative Site
  - Boston, Massachusetts, United States, 02115
    - Available
    - Novartis Investigative Site
  - Boston, Massachusetts, United States, 02178
    - Available
    - Novartis Investigative Site
  - Boston, Massachusetts, United States, 02215
    - Available
    - Novartis Investigative Site
  - Burlington, Massachusetts, United States, 01805
    - Available
    - Novartis Investigative Site
  - Cambridge, Massachusetts, United States, 02138
    - Available
    - Novartis Investigative Site
  - Framingham, Massachusetts, United States, 01702
    - Available
    - Novartis Investigative Site
  - Jamaica Plain, Massachusetts, United States, 02130
    - Available
    - Novartis Investigative Site
  - Springfield, Massachusetts, United States, 01104
    - Available
    - Novartis Investigative Site
  - Worcester, Massachusetts, United States, 01665
    - Available
    - Novartis Investigative Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5848
    - Available
    - Novartis Investigative Site
  - Ann Arbor, Michigan, United States, 48109
    - Available
    - Novartis Investigative Site
  - Bloomfield Hills, Michigan, United States, 48302
    - Available
    - Novartis Investigative Site
  - Dearborn, Michigan, United States, 48126
    - Available
    - Novartis Investigative Site
  - Detroit, Michigan, United States, 48201
    - Available
    - Novartis Investigative Site
  - Detroit, Michigan, United States, 48202 2689
    - Available
    - Novartis Investigative Site
  - Detroit, Michigan, United States, 48202
    - Available
    - Novartis Investigative Site
  - Flint, Michigan, United States, 48503
    - Available
    - Novartis Investigative Site
  - Grand Rapids, Michigan, United States, 49503
    - Available
    - Novartis Investigative Site
  - Jackson, Michigan, United States, 49202
    - Available
    - Novartis Investigative Site
  - Livonia, Michigan, United States, 48154
    - Available
    - Novartis Investigative Site
  - Royal Oak, Michigan, United States, 48073
    - Available
    - Novartis Investigative Site
  - Sterling Heights, Michigan, United States, 48314
    - Available
    - Novartis Investigative Site
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - Available
    - Novartis Investigative Site
  - Mankato, Minnesota, United States, 56001
    - Available
    - Novartis Investigative Site
  - Minneapolis, Minnesota, United States, 55455
    - Available
    - Novartis Investigative Site
  - Rochester, Minnesota, United States, 55905
    - Available
    - Novartis Investigative Site
  - Saint Paul, Minnesota, United States, 55101
    - Available
    - Novartis Investigative Site
  - Saint Paul, Minnesota, United States, 55130
    - Available
    - Novartis Investigative Site
- Mississippi
  - Gulfport, Mississippi, United States, 39501
    - Available
    - Novartis Investigative Site
  - Jackson, Mississippi, United States, 39202
    - Available
    - Novartis Investigative Site
  - Jackson, Mississippi, United States, 39216-4505
    - Available
    - Novartis Investigative Site
- Missouri
  - Kansas City, Missouri, United States, 66160
    - Available
    - Novartis Investigative Site
  - Saint Louis, Missouri, United States, 63104
    - Available
    - Novartis Investigative Site
  - Saint Louis, Missouri, United States, 63110
    - Available
    - Novartis Investigative Site
- Montana
  - Billings, Montana, United States, 59101
    - Available
    - Novartis Investigative Site
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Available
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68114
    - Available
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68131
    - Available
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68198
    - Available
    - Novartis Investigative Site
- Nevada
  - Henderson, Nevada, United States, 89052
    - Available
    - Novartis Investigative Site
  - Las Vegas, Nevada, United States, 89106
    - Available
    - Novartis Investigative Site
  - Pahrump, Nevada, United States, 89048
    - Available
    - Novartis Investigative Site
  - Reno, Nevada, United States, 89502
    - Available
    - Novartis Investigative Site
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Available
    - Novartis Investigative Site
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Available
    - Novartis Investigative Site
  - Hillsborough, New Jersey, United States, 08844
    - Available
    - Novartis Investigative Site
  - Morristown, New Jersey, United States, 07962
    - Available
    - Novartis Investigative Site
  - Newark, New Jersey, United States, 07112
    - Available
    - Novartis Investigative Site
  - Northfield, New Jersey, United States, 08225
    - Available
    - Novartis Investigative Site
  - Somers Point, New Jersey, United States, 08244
    - Available
    - Novartis Investigative Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Available
    - Novartis Investigative Site
- New York
  - Bronx, New York, United States, 10461
    - Available
    - Novartis Investigative Site
  - Bronx, New York, United States, 10467
    - Available
    - Novartis Investigative Site
  - Brooklyn, New York, United States, 11219
    - Available
    - Novartis Investigative Site
  - Flushing, New York, United States, 11355
    - Available
    - Novartis Investigative Site
  - Manhasset, New York, United States, 11030
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10003
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10016
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10017
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10021
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10028
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10029
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10032
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 10065
    - Available
    - Novartis Investigative Site
  - New York, New York, United States, 110032
    - Available
    - Novartis Investigative Site
  - Rochester, New York, United States, 14609
    - Available
    - Novartis Investigative Site
  - Rochester, New York, United States, 14642
    - Available
    - Novartis Investigative Site
  - Stony Brook, New York, United States, 11794-8173
    - Available
    - Novartis Investigative Site
  - Syracuse, New York, United States, 13210
    - Available
    - Novartis Investigative Site
  - Watertown, New York, United States, 13601
    - Available
    - Novartis Investigative Site
  - White Plains, New York, United States, 10604
    - Available
    - Novartis Investigative Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Available
    - Novartis Investigative Site
  - Chapel Hill, North Carolina, United States, 27514
    - Available
    - Novartis Investigative Site
  - Chapel Hill, North Carolina, United States, 27599-7075
    - Available
    - Novartis Investigative Site
  - Chapel Hill, North Carolina, United States, 27599-7600
    - Available
    - Novartis Investigative Site
  - Chapel Hill, North Carolina, United States, 27599-9500
    - Available
    - Novartis Investigative Site
  - Chapel Hill, North Carolina, United States, 27599
    - Available
    - Novartis Investigative Site
  - Durham, North Carolina, United States, 27705
    - Available
    - Novartis Investigative Site
  - Durham, North Carolina, United States, 27710
    - Available
    - Novartis Investigative Site
  - Greensboro, North Carolina, United States, 27401
    - Available
    - Novartis Investigative Site
  - Wilmington, North Carolina, United States, 28401
    - Available
    - Novartis Investigative Site
  - Winston-Salem, North Carolina, United States, 27157
    - Available
    - Novartis Investigative Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Available
    - Novartis Investigative Site
  - Cincinnati, Ohio, United States, 45220
    - Available
    - Novartis Investigative Site
  - Cincinnati, Ohio, United States, 45267-0585
    - Available
    - Novartis Investigative Site
  - Cincinnati, Ohio, United States, 45267
    - Available
    - Novartis Investigative Site
  - Cleveland, Ohio, United States, 44195
    - Available
    - Novartis Investigative Site
  - Columbus, Ohio, United States, 43210
    - Available
    - Novartis Investigative Site
  - Dayton, Ohio, United States, 45404-1815
    - Available
    - Novartis Investigative Site
  - Lakewood, Ohio, United States, 44107
    - Available
    - Novartis Investigative Site
  - Toledo, Ohio, United States, 43606
    - Available
    - Novartis Investigative Site
  - Toledo, Ohio, United States, 43608
    - Available
    - Novartis Investigative Site
  - Toledo, Ohio, United States, 43614
    - Available
    - Novartis Investigative Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Available
    - Novartis Investigative Site
  - Tulsa, Oklahoma, United States, 74136
    - Available
    - Novartis Investigative Site
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Available
    - Novartis Investigative Site
  - Medford, Oregon, United States, 97504
    - Available
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97123
    - Available
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97201
    - Available
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97239
    - Available
    - Novartis Investigative Site
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Available
    - Novartis Investigative Site
  - Allentown, Pennsylvania, United States, 18103
    - Available
    - Novartis Investigative Site
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Available
    - Novartis Investigative Site
  - Danville, Pennsylvania, United States, 17822
    - Available
    - Novartis Investigative Site
  - Doylestown, Pennsylvania, United States, 18901
    - Available
    - Novartis Investigative Site
  - Drexel Hill, Pennsylvania, United States, 19026
    - Available
    - Novartis Investigative Site
  - Erie, Pennsylvania, United States, 16507
    - Available
    - Novartis Investigative Site
  - Greensburg, Pennsylvania, United States, 15604
    - Available
    - Novartis Investigative Site
  - Hershey, Pennsylvania, United States, 17033
    - Available
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19104 4283
    - Available
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - Available
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Available
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19107
    - Available
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Available
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15213-3403
    - Available
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Available
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15224
    - Available
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - Available
    - Novartis Investigative Site
  - Southampton, Pennsylvania, United States, 18966
    - Available
    - Novartis Investigative Site
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Available
    - Novartis Investigative Site
  - Wyomissing, Pennsylvania, United States, 19610
    - Available
    - Novartis Investigative Site
- Rhode Island
  - Providence, Rhode Island, United States, 02906
    - Available
    - Novartis Investigative Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Available
    - Novartis Investigative Site
  - Greenville, South Carolina, United States, 29605
    - Available
    - Novartis Investigative Site
  - Greenville, South Carolina, United States, 29615
    - Available
    - Novartis Investigative Site
  - Spartanburg, South Carolina, United States, 29303
    - Available
    - Novartis Investigative Site
  - West Columbia, South Carolina, United States, 29169
    - Available
    - Novartis Investigative Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Available
    - Novartis Investigative Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Available
    - Novartis Investigative Site
  - Chattanooga, Tennessee, United States, 37404
    - Available
    - Novartis Investigative Site
  - Jackson, Tennessee, United States, 38305
    - Available
    - Novartis Investigative Site
  - Knoxville, Tennessee, United States, 37920
    - Available
    - Novartis Investigative Site
  - Memphis, Tennessee, United States, 38103
    - Available
    - Novartis Investigative Site
  - Memphis, Tennessee, United States, 38104
    - Available
    - Novartis Investigative Site
  - Memphis, Tennessee, United States, 38157
    - Available
    - Novartis Investigative Site
- Texas
  - Dallas, Texas, United States, 75246
    - Available
    - Novartis Investigative Site
  - Dallas, Texas, United States, 75390
    - Available
    - Novartis Investigative Site
  - El Paso, Texas, United States, 79905
    - Available
    - Novartis Investigative Site
  - Galveston, Texas, United States, 77555-0783
    - Available
    - Novartis Investigative Site
  - Houston, Texas, United States, 77025
    - Available
    - Novartis Investigative Site
  - McKinney, Texas, United States, 75069
    - Available
    - Novartis Investigative Site
  - San Antonio, Texas, United States, 78229-4404
    - Available
    - Novartis Investigative Site
  - San Antonio, Texas, United States, 78229
    - Available
    - Novartis Investigative Site
  - San Antonio, Texas, United States, 78284
    - Available
    - Novartis Investigative Site
  - The Woodlands, Texas, United States, 77385
    - Available
    - Novartis Investigative Site
  - Tyler, Texas, United States, 75708
    - Available
    - Novartis Investigative Site
- Utah
  - Salt Lake City, Utah, United States, 84108
    - Available
    - Novartis Investigative Site
  - Salt Lake City, Utah, United States, 84132
    - Available
    - Novartis Investigative Site
- Virginia
  - Annandale, Virginia, United States, 22003-7360
    - Available
    - Novartis Investigative Site
  - Annandale, Virginia, United States, 22003
    - Available
    - Novartis Investigative Site
  - Arlington, Virginia, United States, 22205
    - Available
    - Novartis Investigative Site
  - Charlottesville, Virginia, United States, 22908-0334
    - Available
    - Novartis Investigative Site
  - Charlottesville, Virginia, United States, 22911
    - Available
    - Novartis Investigative Site
  - Portsmouth, Virginia, United States, 23708
    - Available
    - Novartis Investigative Site
  - Richmond, Virginia, United States, 23298
    - Available
    - Novartis Investigative Site
  - Salem, Virginia, United States, 24153
    - Available
    - Novartis Investigative Site
- Washington
  - Everett, Washington, United States, 98201
    - Available
    - Novartis Investigative Site
  - Kirkland, Washington, United States, 98034
    - Available
    - Novartis Investigative Site
  - Seattle, Washington, United States, 98108
    - Available
    - Novartis Investigative Site
  - Seattle, Washington, United States, 98109
    - Available
    - Novartis Investigative Site
  - Tacoma, Washington, United States, 98405
    - Available
    - Novartis Investigative Site
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Available
    - Novartis Investigative Site
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - Available
    - Novartis Investigative Site
  - Greenfield, Wisconsin, United States, 53221
    - Available
    - Novartis Investigative Site
  - Milwaukee, Wisconsin, United States, 53215
    - Available
    - Novartis Investigative Site
  - Milwaukee, Wisconsin, United States, 53226
    - Available
    - Novartis Investigative Site
  - Milwaukee, Wisconsin, United States, 53233
    - Available
    - Novartis Investigative Site
  - Milwaukee, Wisconsin, United States, 55902
    - Available
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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
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
Female patients of child-bearing potential with negative pregnancy test before clofazimine treatment initiation and who confirm no intention to become pregnant during the treatment with clofazimine, by using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while taking clofazimine treatment and for at least 4 months after stopping treatment with clofazimine

Exclusion Criteria:

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
Any condition (social, psychiatric, or medical) which in the opinion of the treating physician would make participation in this MPP unsafe
Unable to swallow capsules
HIV-infected patients with disseminated NTM infection
Life expectancy less than 6 months
Pregnant or nursing (lactating) females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CLAM320B2002M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Expanded Access Type

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Collaborators and Investigators

Sponsor

Study record dates

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Non-Tuberculous Mycobacterial (NTM) Infections

Clinical Trials on Lamprene®/Clofazimine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations