Lamprene Multiple Patient Program

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Available
CT.gov ID
NCT04334070
Collaborator
(none)
292

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Novartis Multiple Patient Program for Lamprene® (Clofazimine) for the Treatment of Non-Tuberculous Mycobacterial (NTM) Infections

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 is performed.

    3. Patients previously diagnosed with NTM infection with local or disseminated infection(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 baseline macrolide resistance or for whom an appropriate regimen cannot otherwise be devised

    5. 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

    6. 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:
    1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as clofazimine

    2. 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)

    3. 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

    4. Confirmed demonstration of resting QTcF >500 msec at screening

    5. Any condition (social, psychiatric, or medical) which in the opinion of the treating physician 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Birmingham Alabama United States 35205
    2 Novartis Investigative Site Birmingham Alabama United States 35233-1711
    3 Novartis Investigative Site Birmingham Alabama United States 35294-0006
    4 Novartis Investigative Site Birmingham Alabama United States 35294
    5 Novartis Investigative Site Mobile Alabama United States 36608-1128
    6 Novartis Investigative Site Anchorage Alaska United States 99508
    7 Novartis Investigative Site Phoenix Arizona United States 85006
    8 Novartis Investigative Site Phoenix Arizona United States 85013
    9 Novartis Investigative Site Phoenix Arizona United States 85032
    10 Novartis Investigative Site Phoenix Arizona United States 85054
    11 Novartis Investigative Site Little Rock Arkansas United States 72205
    12 Novartis Investigative Site Bellflower California United States 90706
    13 Novartis Investigative Site Duarte California United States 91010
    14 Novartis Investigative Site Fontana California United States 92335
    15 Novartis Investigative Site Loma Linda California United States 92354
    16 Novartis Investigative Site Los Angeles California United States 90005-1752
    17 Novartis Investigative Site Los Angeles California United States 90017
    18 Novartis Investigative Site Los Angeles California United States 90033-4605
    19 Novartis Investigative Site Los Angeles California United States 90033
    20 Novartis Investigative Site Los Angeles California United States 90036
    21 Novartis Investigative Site Los Angeles California United States 90048
    22 Novartis Investigative Site Los Angeles California United States 90073
    23 Novartis Investigative Site Los Angeles California United States 90095-1752
    24 Novartis Investigative Site Los Angeles California United States 90095-1793
    25 Novartis Investigative Site Los Angeles California United States 90095
    26 Novartis Investigative Site Palo Alto California United States 94304
    27 Novartis Investigative Site Panorama City California United States 91402
    28 Novartis Investigative Site Pasadena California United States 91105
    29 Novartis Investigative Site San Diego California United States 92103
    30 Novartis Investigative Site San Diego California United States 92134
    31 Novartis Investigative Site San Francisco California United States 94143
    32 Novartis Investigative Site San Jose California United States 95119 1130
    33 Novartis Investigative Site San Luis Obispo California United States 93401
    34 Novartis Investigative Site Santa Barbara California United States 93105
    35 Novartis Investigative Site Santa Monica California United States 90404
    36 Novartis Investigative Site Stanford California United States 94305
    37 Novartis Investigative Site Torrance California United States 90509
    38 Novartis Investigative Site Travis Air Force Base California United States 94535
    39 Novartis Investigative Site Walnut Creek California United States 94598
    40 Novartis Investigative Site Denver Colorado United States 80205
    41 Novartis Investigative Site Denver Colorado United States 80206
    42 Novartis Investigative Site Denver Colorado United States 80218
    43 Novartis Investigative Site Fort Collins Colorado United States 80526
    44 Novartis Investigative Site Wheat Ridge Colorado United States 80033
    45 Novartis Investigative Site Danbury Connecticut United States 06810
    46 Novartis Investigative Site Waterbury Connecticut United States 06708
    47 Novartis Investigative Site Newark Delaware United States 19713
    48 Novartis Investigative Site Newark Delaware United States 19718
    49 Novartis Investigative Site Wilmington Delaware United States 19718
    50 Novartis Investigative Site Washington District of Columbia United States 20007
    51 Novartis Investigative Site Washington District of Columbia United States 20016
    52 Novartis Investigative Site Washington District of Columbia United States 20057
    53 Novartis Investigative Site Washington District of Columbia United States 20307-0003
    54 Novartis Investigative Site Aventura Florida United States 33180
    55 Novartis Investigative Site Delray Beach Florida United States 33445
    56 Novartis Investigative Site Fort Lauderdale Florida United States 33308
    57 Novartis Investigative Site Fort Myers Florida United States 33908
    58 Novartis Investigative Site Gainesville Florida United States 32610
    59 Novartis Investigative Site Hollywood Florida United States 33021
    60 Novartis Investigative Site Jacksonville Florida United States 32207
    61 Novartis Investigative Site Jacksonville Florida United States 32224
    62 Novartis Investigative Site Kissimmee Florida United States 34741
    63 Novartis Investigative Site Leesburg Florida United States 34748
    64 Novartis Investigative Site Miami Beach Florida United States 33140
    65 Novartis Investigative Site Miami Florida United States 33136
    66 Novartis Investigative Site Miami Florida United States 33173
    67 Novartis Investigative Site Naples Florida United States 34102
    68 Novartis Investigative Site Orlando Florida United States 32803
    69 Novartis Investigative Site Orlando Florida United States 32804
    70 Novartis Investigative Site Orlando Florida United States 32806
    71 Novartis Investigative Site Sarasota Florida United States 34239
    72 Novartis Investigative Site South Miami Florida United States 33143
    73 Novartis Investigative Site Tampa Florida United States 33606
    74 Novartis Investigative Site Tampa Florida United States 33612
    75 Novartis Investigative Site Tampa Florida United States 33614
    76 Novartis Investigative Site Weston Florida United States 33331
    77 Novartis Investigative Site Winter Park Florida United States 32792
    78 Novartis Investigative Site Atlanta Georgia United States 30309
    79 Novartis Investigative Site Atlanta Georgia United States 30322
    80 Novartis Investigative Site Atlanta Georgia United States 30342
    81 Novartis Investigative Site Augusta Georgia United States 30912
    82 Novartis Investigative Site Decatur Georgia United States 30033
    83 Novartis Investigative Site Honolulu Hawaii United States 96813
    84 Novartis Investigative Site Honolulu Hawaii United States 96814
    85 Novartis Investigative Site Lihue Hawaii United States 96766
    86 Novartis Investigative Site Boise Idaho United States 83712
    87 Novartis Investigative Site Chicago Illinois United States 60612
    88 Novartis Investigative Site Chicago Illinois United States 60616
    89 Novartis Investigative Site Chicago Illinois United States 60637
    90 Novartis Investigative Site Peoria Illinois United States 61637
    91 Novartis Investigative Site Springfield Illinois United States 62703
    92 Novartis Investigative Site Urbana Illinois United States 61801
    93 Novartis Investigative Site Indianapolis Indiana United States 46202-5111
    94 Novartis Investigative Site Indianapolis Indiana United States 46202
    95 Novartis Investigative Site Clive Iowa United States 50325
    96 Novartis Investigative Site Iowa City Iowa United States 52242
    97 Novartis Investigative Site Fairway Kansas United States 66205
    98 Novartis Investigative Site Kansas City Kansas United States 66160-7820
    99 Novartis Investigative Site Kansas City Kansas United States 66160
    100 Novartis Investigative Site Westwood Kansas United States 66205
    101 Novartis Investigative Site Wichita Kansas United States 67230
    102 Novartis Investigative Site Lexington Kentucky United States 40503
    103 Novartis Investigative Site Lexington Kentucky United States 40511
    104 Novartis Investigative Site Lexington Kentucky United States 40536
    105 Novartis Investigative Site Paducah Kentucky United States 42001
    106 Novartis Investigative Site Baton Rouge Louisiana United States 70808
    107 Novartis Investigative Site Baton Rouge Louisiana United States 70809
    108 Novartis Investigative Site New Orleans Louisiana United States 70112-1328
    109 Novartis Investigative Site New Orleans Louisiana United States 70112-2699
    110 Novartis Investigative Site New Orleans Louisiana United States 70112
    111 Novartis Investigative Site New Orleans Louisiana United States 70115
    112 Novartis Investigative Site New Orleans Louisiana United States 70121
    113 Novartis Investigative Site Baltimore Maryland United States 21201
    114 Novartis Investigative Site Baltimore Maryland United States 21204
    115 Novartis Investigative Site Baltimore Maryland United States 21224
    116 Novartis Investigative Site Baltimore Maryland United States 21287
    117 Novartis Investigative Site Bethesda Maryland United States 20892
    118 Novartis Investigative Site Columbia Maryland United States 21045
    119 Novartis Investigative Site Largo Maryland United States 20774
    120 Novartis Investigative Site Boston Massachusetts United States 02111
    121 Novartis Investigative Site Boston Massachusetts United States 02114
    122 Novartis Investigative Site Boston Massachusetts United States 02115
    123 Novartis Investigative Site Boston Massachusetts United States 02178
    124 Novartis Investigative Site Boston Massachusetts United States 02215
    125 Novartis Investigative Site Burlington Massachusetts United States 01805
    126 Novartis Investigative Site Cambridge Massachusetts United States 02138
    127 Novartis Investigative Site Framingham Massachusetts United States 01702
    128 Novartis Investigative Site Jamaica Plain Massachusetts United States 02130
    129 Novartis Investigative Site Springfield Massachusetts United States 01104
    130 Novartis Investigative Site Worcester Massachusetts United States 01665
    131 Novartis Investigative Site Ann Arbor Michigan United States 48109-5848
    132 Novartis Investigative Site Ann Arbor Michigan United States 48109
    133 Novartis Investigative Site Bloomfield Hills Michigan United States 48302
    134 Novartis Investigative Site Dearborn Michigan United States 48126
    135 Novartis Investigative Site Detroit Michigan United States 48201
    136 Novartis Investigative Site Detroit Michigan United States 48202 2689
    137 Novartis Investigative Site Detroit Michigan United States 48202
    138 Novartis Investigative Site Flint Michigan United States 48503
    139 Novartis Investigative Site Grand Rapids Michigan United States 49503
    140 Novartis Investigative Site Jackson Michigan United States 49202
    141 Novartis Investigative Site Livonia Michigan United States 48154
    142 Novartis Investigative Site Royal Oak Michigan United States 48073
    143 Novartis Investigative Site Sterling Heights Michigan United States 48314
    144 Novartis Investigative Site Duluth Minnesota United States 55805
    145 Novartis Investigative Site Mankato Minnesota United States 56001
    146 Novartis Investigative Site Minneapolis Minnesota United States 55455
    147 Novartis Investigative Site Rochester Minnesota United States 55905
    148 Novartis Investigative Site Saint Paul Minnesota United States 55101
    149 Novartis Investigative Site Saint Paul Minnesota United States 55130
    150 Novartis Investigative Site Gulfport Mississippi United States 39501
    151 Novartis Investigative Site Jackson Mississippi United States 39202
    152 Novartis Investigative Site Jackson Mississippi United States 39216-4505
    153 Novartis Investigative Site Kansas City Missouri United States 66160
    154 Novartis Investigative Site Saint Louis Missouri United States 63104
    155 Novartis Investigative Site Saint Louis Missouri United States 63110
    156 Novartis Investigative Site Billings Montana United States 59101
    157 Novartis Investigative Site Lincoln Nebraska United States 68506
    158 Novartis Investigative Site Omaha Nebraska United States 68114
    159 Novartis Investigative Site Omaha Nebraska United States 68131
    160 Novartis Investigative Site Omaha Nebraska United States 68198
    161 Novartis Investigative Site Henderson Nevada United States 89052
    162 Novartis Investigative Site Las Vegas Nevada United States 89106
    163 Novartis Investigative Site Pahrump Nevada United States 89048
    164 Novartis Investigative Site Reno Nevada United States 89502
    165 Novartis Investigative Site Lebanon New Hampshire United States 03756
    166 Novartis Investigative Site Flemington New Jersey United States 08822
    167 Novartis Investigative Site Hillsborough New Jersey United States 08844
    168 Novartis Investigative Site Morristown New Jersey United States 07962
    169 Novartis Investigative Site Newark New Jersey United States 07112
    170 Novartis Investigative Site Northfield New Jersey United States 08225
    171 Novartis Investigative Site Somers Point New Jersey United States 08244
    172 Novartis Investigative Site Albuquerque New Mexico United States 87131
    173 Novartis Investigative Site Bronx New York United States 10461
    174 Novartis Investigative Site Bronx New York United States 10467
    175 Novartis Investigative Site Brooklyn New York United States 11219
    176 Novartis Investigative Site Flushing New York United States 11355
    177 Novartis Investigative Site Manhasset New York United States 11030
    178 Novartis Investigative Site New York New York United States 10003
    179 Novartis Investigative Site New York New York United States 10016
    180 Novartis Investigative Site New York New York United States 10017
    181 Novartis Investigative Site New York New York United States 10021
    182 Novartis Investigative Site New York New York United States 10028
    183 Novartis Investigative Site New York New York United States 10029
    184 Novartis Investigative Site New York New York United States 10032
    185 Novartis Investigative Site New York New York United States 10065
    186 Novartis Investigative Site New York New York United States 110032
    187 Novartis Investigative Site Rochester New York United States 14609
    188 Novartis Investigative Site Rochester New York United States 14642
    189 Novartis Investigative Site Stony Brook New York United States 11794-8173
    190 Novartis Investigative Site Syracuse New York United States 13210
    191 Novartis Investigative Site Watertown New York United States 13601
    192 Novartis Investigative Site White Plains New York United States 10604
    193 Novartis Investigative Site Asheville North Carolina United States 28803
    194 Novartis Investigative Site Chapel Hill North Carolina United States 27514
    195 Novartis Investigative Site Chapel Hill North Carolina United States 27599-7075
    196 Novartis Investigative Site Chapel Hill North Carolina United States 27599-7600
    197 Novartis Investigative Site Chapel Hill North Carolina United States 27599-9500
    198 Novartis Investigative Site Chapel Hill North Carolina United States 27599
    199 Novartis Investigative Site Durham North Carolina United States 27705
    200 Novartis Investigative Site Durham North Carolina United States 27710
    201 Novartis Investigative Site Greensboro North Carolina United States 27401
    202 Novartis Investigative Site Wilmington North Carolina United States 28401
    203 Novartis Investigative Site Winston-Salem North Carolina United States 27157
    204 Novartis Investigative Site Cincinnati Ohio United States 45219
    205 Novartis Investigative Site Cincinnati Ohio United States 45220
    206 Novartis Investigative Site Cincinnati Ohio United States 45267-0585
    207 Novartis Investigative Site Cincinnati Ohio United States 45267
    208 Novartis Investigative Site Cleveland Ohio United States 44195
    209 Novartis Investigative Site Columbus Ohio United States 43210
    210 Novartis Investigative Site Dayton Ohio United States 45404-1815
    211 Novartis Investigative Site Lakewood Ohio United States 44107
    212 Novartis Investigative Site Toledo Ohio United States 43606
    213 Novartis Investigative Site Toledo Ohio United States 43608
    214 Novartis Investigative Site Toledo Ohio United States 43614
    215 Novartis Investigative Site Oklahoma City Oklahoma United States 73112
    216 Novartis Investigative Site Tulsa Oklahoma United States 74136
    217 Novartis Investigative Site Clackamas Oregon United States 97015
    218 Novartis Investigative Site Medford Oregon United States 97504
    219 Novartis Investigative Site Portland Oregon United States 97123
    220 Novartis Investigative Site Portland Oregon United States 97201
    221 Novartis Investigative Site Portland Oregon United States 97239
    222 Novartis Investigative Site Abington Pennsylvania United States 19001
    223 Novartis Investigative Site Allentown Pennsylvania United States 18103
    224 Novartis Investigative Site Bryn Mawr Pennsylvania United States 19010
    225 Novartis Investigative Site Danville Pennsylvania United States 17822
    226 Novartis Investigative Site Doylestown Pennsylvania United States 18901
    227 Novartis Investigative Site Drexel Hill Pennsylvania United States 19026
    228 Novartis Investigative Site Erie Pennsylvania United States 16507
    229 Novartis Investigative Site Greensburg Pennsylvania United States 15604
    230 Novartis Investigative Site Hershey Pennsylvania United States 17033
    231 Novartis Investigative Site Philadelphia Pennsylvania United States 19104 4283
    232 Novartis Investigative Site Philadelphia Pennsylvania United States 19104-4283
    233 Novartis Investigative Site Philadelphia Pennsylvania United States 19104
    234 Novartis Investigative Site Philadelphia Pennsylvania United States 19107
    235 Novartis Investigative Site Philadelphia Pennsylvania United States 19140
    236 Novartis Investigative Site Pittsburgh Pennsylvania United States 15213-3403
    237 Novartis Investigative Site Pittsburgh Pennsylvania United States 15213
    238 Novartis Investigative Site Pittsburgh Pennsylvania United States 15224
    239 Novartis Investigative Site Pittsburgh Pennsylvania United States 15243
    240 Novartis Investigative Site Southampton Pennsylvania United States 18966
    241 Novartis Investigative Site Wilkes-Barre Pennsylvania United States 18711
    242 Novartis Investigative Site Wyomissing Pennsylvania United States 19610
    243 Novartis Investigative Site Providence Rhode Island United States 02906
    244 Novartis Investigative Site Charleston South Carolina United States 29425
    245 Novartis Investigative Site Greenville South Carolina United States 29605
    246 Novartis Investigative Site Greenville South Carolina United States 29615
    247 Novartis Investigative Site Spartanburg South Carolina United States 29303
    248 Novartis Investigative Site West Columbia South Carolina United States 29169
    249 Novartis Investigative Site Sioux Falls South Dakota United States 57105
    250 Novartis Investigative Site Chattanooga Tennessee United States 37403
    251 Novartis Investigative Site Chattanooga Tennessee United States 37404
    252 Novartis Investigative Site Jackson Tennessee United States 38305
    253 Novartis Investigative Site Knoxville Tennessee United States 37920
    254 Novartis Investigative Site Memphis Tennessee United States 38103
    255 Novartis Investigative Site Memphis Tennessee United States 38104
    256 Novartis Investigative Site Memphis Tennessee United States 38157
    257 Novartis Investigative Site Dallas Texas United States 75246
    258 Novartis Investigative Site Dallas Texas United States 75390
    259 Novartis Investigative Site El Paso Texas United States 79905
    260 Novartis Investigative Site Galveston Texas United States 77555-0783
    261 Novartis Investigative Site Houston Texas United States 77025
    262 Novartis Investigative Site McKinney Texas United States 75069
    263 Novartis Investigative Site San Antonio Texas United States 78229-4404
    264 Novartis Investigative Site San Antonio Texas United States 78229
    265 Novartis Investigative Site San Antonio Texas United States 78284
    266 Novartis Investigative Site The Woodlands Texas United States 77385
    267 Novartis Investigative Site Tyler Texas United States 75708
    268 Novartis Investigative Site Salt Lake City Utah United States 84108
    269 Novartis Investigative Site Salt Lake City Utah United States 84132
    270 Novartis Investigative Site Annandale Virginia United States 22003-7360
    271 Novartis Investigative Site Annandale Virginia United States 22003
    272 Novartis Investigative Site Arlington Virginia United States 22205
    273 Novartis Investigative Site Charlottesville Virginia United States 22908-0334
    274 Novartis Investigative Site Charlottesville Virginia United States 22911
    275 Novartis Investigative Site Portsmouth Virginia United States 23708
    276 Novartis Investigative Site Richmond Virginia United States 23298
    277 Novartis Investigative Site Salem Virginia United States 24153
    278 Novartis Investigative Site Everett Washington United States 98201
    279 Novartis Investigative Site Kirkland Washington United States 98034
    280 Novartis Investigative Site Seattle Washington United States 98108
    281 Novartis Investigative Site Seattle Washington United States 98109
    282 Novartis Investigative Site Tacoma Washington United States 98405
    283 Novartis Investigative Site Morgantown West Virginia United States 26506
    284 Novartis Investigative Site Eau Claire Wisconsin United States 54701
    285 Novartis Investigative Site Greenfield Wisconsin United States 53221
    286 Novartis Investigative Site Milwaukee Wisconsin United States 53215
    287 Novartis Investigative Site Milwaukee Wisconsin United States 53226
    288 Novartis Investigative Site Milwaukee Wisconsin United States 53233
    289 Novartis Investigative Site Milwaukee Wisconsin United States 55902
    290 Novartis Investigative Site Calgary Alberta Canada T1Y 6J4
    291 Novartis Investigative Site Toronto Ontario Canada M5G 1X8
    292 Novartis Investigative Site Toronto Ontario Canada M5T 2S8

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04334070
    Other Study ID Numbers:
    • CLAM320B2002M
    First Posted:
    Apr 3, 2020
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021