Official Title
Novartis Multiple Patient Program for Lamprene® (Clofazimine) for the Treatment of Non-Tuberculous Mycobacterial (NTM) Infections
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.

Available
Intermediate-size Population
Non-Tuberculous Mycobacterial (NTM) Infections

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 Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Canada
United States
Locations

Novartis Investigative Site
Birmingham, Alabama, 35205

Available

Novartis Investigative Site
Birmingham, Alabama, 35294

Available

Novartis Investigative Site
Mobile, Alabama, 36608-1128

Available

Novartis Investigative Site
Anchorage, Alaska, 99508

Available

Novartis Investigative Site
Phoenix, Arizona, 85006

Available

Novartis Investigative Site
Phoenix, Arizona, 85032

Available

Novartis Investigative Site
Phoenix, Arizona, 85054

Available

Novartis Investigative Site
Little Rock, Arkansas, 72205

Available

Novartis Investigative Site
Bellflower, California, 90706

Available

Novartis Investigative Site
Duarte, California, 91010

Available

Novartis Investigative Site
Fontana, California, 92335

Available

Novartis Investigative Site
Loma Linda, California, 92354

Available

Novartis Investigative Site
Los Angeles, California, 90005-1752

Available

Novartis Investigative Site
Los Angeles, California, 90017

Available

Novartis Investigative Site
Los Angeles, California, 90033

Available

Novartis Investigative Site
Los Angeles, California, 90036

Available

Novartis Investigative Site
Los Angeles, California, 90048

Available

Novartis Investigative Site
Los Angeles, California, 90073

Available

Novartis Investigative Site
Los Angeles, California, 90095

Available

Novartis Investigative Site
Palo Alto, California, 94304

Available

Novartis Investigative Site
Panorama City, California, 91402

Available

Novartis Investigative Site
Pasadena, California, 91105

Available

Novartis Investigative Site
San Diego, California, 92103

Available

Novartis Investigative Site
San Diego, California, 92134

Available

Novartis Investigative Site
San Francisco, California, 94143

Available

Novartis Investigative Site
San Jose, California, 95119 1130

Available

Novartis Investigative Site
San Luis Obispo, California, 93401

Available

Novartis Investigative Site
Santa Barbara, California, 93105

Available

Novartis Investigative Site
Santa Monica, California, 90404

Available

Novartis Investigative Site
Stanford, California, 94305

Available

Novartis Investigative Site
Torrance, California, 90509

Available

Novartis Investigative Site
Travis Air Force Base, California, 94535

Available

Novartis Investigative Site
Denver, Colorado, 80205

Available

Novartis Investigative Site
Denver, Colorado, 80206

Available

Novartis Investigative Site
Denver, Colorado, 80218

Available

Novartis Investigative Site
Fort Collins, Colorado, 80526

Available

Novartis Investigative Site
Wheat Ridge, Colorado, 80033

Available

Novartis Investigative Site
Newark, Delaware, 19718

Available

Novartis Investigative Site
Wilmington, Delaware, 19718

Available

Novartis Investigative Site
Washington, District of Columbia, 20007

Available

Novartis Investigative Site
Washington, District of Columbia, 20016

Available

Novartis Investigative Site
Washington, District of Columbia, 20307-0003

Available

Novartis Investigative Site
Aventura, Florida, 33180

Available

Novartis Investigative Site
Delray Beach, Florida, 33445

Available

Novartis Investigative Site
Fort Lauderdale, Florida, 33308

Available

Novartis Investigative Site
Fort Myers, Florida, 33908

Available

Novartis Investigative Site
Gainesville, Florida, 32610

Available

Novartis Investigative Site
Hollywood, Florida, 33021

Available

Novartis Investigative Site
Jacksonville, Florida, 32207

Available

Novartis Investigative Site
Jacksonville, Florida, 32224

Available

Novartis Investigative Site
Leesburg, Florida, 34748

Available

Novartis Investigative Site
Miami Beach, Florida, 33140

Available

Novartis Investigative Site
Miami, Florida, 33136

Available

Novartis Investigative Site
Miami, Florida, 33173

Available

Novartis Investigative Site
Naples, Florida, 34102

Available

Novartis Investigative Site
Orlando, Florida, 32803

Available

Novartis Investigative Site
Orlando, Florida, 32804

Available

Novartis Investigative Site
Orlando, Florida, 32806

Available

Novartis Investigative Site
Sarasota, Florida, 34239

Available

Novartis Investigative Site
South Miami, Florida, 33143

Available

Novartis Investigative Site
Tampa, Florida, 33606

Available

Novartis Investigative Site
Tampa, Florida, 33612

Available

Novartis Investigative Site
Tampa, Florida, 33614

Available

Novartis Investigative Site
Winter Park, Florida, 32792

Available

Novartis Investigative Site
Atlanta, Georgia, 30309

Available

Novartis Investigative Site
Atlanta, Georgia, 30322

Available

Novartis Investigative Site
Atlanta, Georgia, 30342

Available

Novartis Investigative Site
Augusta, Georgia, 30912

Available

Novartis Investigative Site
Decatur, Georgia, 30033

Available

Novartis Investigative Site
Honolulu, Hawaii, 96813

Available

Novartis Investigative Site
Lihue, Hawaii, 96766

Available

Novartis Investigative Site
Boise, Idaho, 83712

Available

Novartis Investigative Site
Chicago, Illinois, 60616

Available

Novartis Investigative Site
Chicago, Illinois, 60637

Available

Novartis Investigative Site
Peoria, Illinois, 61637

Available

Novartis Investigative Site
Springfield, Illinois, 62703

Available

Novartis Investigative Site
Urbana, Illinois, 61801

Available

Novartis Investigative Site
Indianapolis, Indiana, 46202-5111

Available

Novartis Investigative Site
Indianapolis, Indiana, 46202

Available

Novartis Investigative Site
Clive, Iowa, 50325

Available

Novartis Investigative Site
Iowa City, Iowa, 52242

Available

Novartis Investigative Site
Kansas City, Kansas, 66160-7820

Available

Novartis Investigative Site
Kansas City, Kansas, 66160

Available

Novartis Investigative Site
Westwood, Kansas, 66205

Available

Novartis Investigative Site
Lexington, Kentucky, 40503

Available

Novartis Investigative Site
Lexington, Kentucky, 40511

Available

Novartis Investigative Site
Paducah, Kentucky, 42001

Available

Novartis Investigative Site
Baton Rouge, Louisiana, 70808

Available

Novartis Investigative Site
Baton Rouge, Louisiana, 70809

Available

Novartis Investigative Site
New Orleans, Louisiana, 70112-2699

Available

Novartis Investigative Site
New Orleans, Louisiana, 70112

Available

Novartis Investigative Site
Baltimore, Maryland, 21201

Available

Novartis Investigative Site
Baltimore, Maryland, 21204

Available

Novartis Investigative Site
Baltimore, Maryland, 21224

Available

Novartis Investigative Site
Baltimore, Maryland, 21287

Available

Novartis Investigative Site
Bethesda, Maryland, 20892

Available

Novartis Investigative Site
Columbia, Maryland, 21045

Available

Novartis Investigative Site
Largo, Maryland, 20774

Available

Novartis Investigative Site
Boston, Massachusetts, 02111

Available

Novartis Investigative Site
Boston, Massachusetts, 02114

Available

Novartis Investigative Site
Boston, Massachusetts, 02115

Available

Novartis Investigative Site
Boston, Massachusetts, 02178

Available

Novartis Investigative Site
Boston, Massachusetts, 02215

Available

Novartis Investigative Site
Burlington, Massachusetts, 01805

Available

Novartis Investigative Site
Cambridge, Massachusetts, 02138

Available

Novartis Investigative Site
Framingham, Massachusetts, 01702

Available

Novartis Investigative Site
Springfield, Massachusetts, 01104

Available

Novartis Investigative Site
Worcester, Massachusetts, 01665

Available

Novartis Investigative Site
Ann Arbor, Michigan, 48109

Available

Novartis Investigative Site
Bloomfield Hills, Michigan, 48302

Available

Novartis Investigative Site
Dearborn, Michigan, 48126

Available

Novartis Investigative Site
Detroit, Michigan, 48201

Available

Novartis Investigative Site
Detroit, Michigan, 48202 2689

Available

Novartis Investigative Site
Detroit, Michigan, 48202

Available

Novartis Investigative Site
Grand Rapids, Michigan, 49503

Available

Novartis Investigative Site
Jackson, Michigan, 49202

Available

Novartis Investigative Site
Livonia, Michigan, 48154

Available

Novartis Investigative Site
Royal Oak, Michigan, 48073

Available

Novartis Investigative Site
Sterling Heights, Michigan, 48314

Available

Novartis Investigative Site
Mankato, Minnesota, 56001

Available

Novartis Investigative Site
Minneapolis, Minnesota, 55455

Available

Novartis Investigative Site
Rochester, Minnesota, 55905

Available

Novartis Investigative Site
Saint Paul, Minnesota, 55130

Available

Novartis Investigative Site
Jackson, Mississippi, 39202

Available

Novartis Investigative Site
Jackson, Mississippi, 39216-4505

Available

Novartis Investigative Site
Kansas City, Missouri, 66160

Available

Novartis Investigative Site
Saint Louis, Missouri, 63104

Available

Novartis Investigative Site
Saint Louis, Missouri, 63110

Available

Novartis Investigative Site
Billings, Montana, 59101

Available

Novartis Investigative Site
Omaha, Nebraska, 68131

Available

Novartis Investigative Site
Omaha, Nebraska, 68198

Available

Novartis Investigative Site
Henderson, Nevada, 89052

Available

Novartis Investigative Site
Pahrump, Nevada, 89048

Available

Novartis Investigative Site
Lebanon, New Hampshire, 03756

Available

Novartis Investigative Site
Flemington, New Jersey, 08822

Available

Novartis Investigative Site
Hillsborough, New Jersey, 08844

Available

Novartis Investigative Site
Northfield, New Jersey, 08225

Available

Novartis Investigative Site
Somers Point, New Jersey, 08244

Available

Novartis Investigative Site
Albuquerque, New Mexico, 87131

Available

Novartis Investigative Site
Bronx, New York, 10461

Available

Novartis Investigative Site
Bronx, New York, 10467

Available

Novartis Investigative Site
Brooklyn, New York, 11219

Available

Novartis Investigative Site
Manhasset, New York, 11030

Available

Novartis Investigative Site
New York, New York, 10003

Available

Novartis Investigative Site
New York, New York, 10016

Available

Novartis Investigative Site
New York, New York, 10021

Available

Novartis Investigative Site
New York, New York, 10028

Available

Novartis Investigative Site
New York, New York, 10029

Available

Novartis Investigative Site
New York, New York, 10032

Available

Novartis Investigative Site
New York, New York, 10065

Available

Novartis Investigative Site
New York, New York, 110032

Available

Novartis Investigative Site
Rochester, New York, 14609

Available

Novartis Investigative Site
Stony Brook, New York, 11794-8173

Available

Novartis Investigative Site
Asheville, North Carolina, 28803

Available

Novartis Investigative Site
Chapel Hill, North Carolina, 27599-9500

Available

Novartis Investigative Site
Chapel Hill, North Carolina, 27599

Available

Novartis Investigative Site
Durham, North Carolina, 27710

Available

Novartis Investigative Site
Greensboro, North Carolina, 27401

Available

Novartis Investigative Site
Wilmington, North Carolina, 28401

Available

Novartis Investigative Site
Winston-Salem, North Carolina, 27157

Available

Novartis Investigative Site
Cincinnati, Ohio, 45220

Available

Novartis Investigative Site
Cincinnati, Ohio, 45267

Available

Novartis Investigative Site
Cleveland, Ohio, 44195

Available

Novartis Investigative Site
Columbus, Ohio, 43210

Available

Novartis Investigative Site
Dayton, Ohio, 45404-1815

Available

Novartis Investigative Site
Lakewood, Ohio, 44107

Available

Novartis Investigative Site
Toledo, Ohio, 43614

Available

Novartis Investigative Site
Oklahoma City, Oklahoma, 73112

Available

Novartis Investigative Site
Tulsa, Oklahoma, 74136

Available

Novartis Investigative Site
Medford, Oregon, 97504

Available

Novartis Investigative Site
Portland, Oregon, 97123

Available

Novartis Investigative Site
Portland, Oregon, 97239

Available

Novartis Investigative Site
Abington, Pennsylvania, 19001

Available

Novartis Investigative Site
Allentown, Pennsylvania, 18103

Available

Novartis Investigative Site
Bryn Mawr, Pennsylvania, 19010

Available

Novartis Investigative Site
Drexel Hill, Pennsylvania, 19026

Available

Novartis Investigative Site
Erie, Pennsylvania, 16507

Available

Novartis Investigative Site
Greensburg, Pennsylvania, 15604

Available

Novartis Investigative Site
Hershey, Pennsylvania, 17033

Available

Novartis Investigative Site
Philadelphia, Pennsylvania, 19104

Available

Novartis Investigative Site
Philadelphia, Pennsylvania, 19107

Available

Novartis Investigative Site
Philadelphia, Pennsylvania, 19140

Available

Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213

Available

Novartis Investigative Site
Pittsburgh, Pennsylvania, 15224

Available

Novartis Investigative Site
Southampton, Pennsylvania, 18966

Available

Novartis Investigative Site
Providence, Rhode Island, 02906

Available

Novartis Investigative Site
Charleston, South Carolina, 29425

Available

Novartis Investigative Site
Greenville, South Carolina, 29605

Available

Novartis Investigative Site
Greenville, South Carolina, 29615

Available

Novartis Investigative Site
West Columbia, South Carolina, 29169

Available

Novartis Investigative Site
Sioux Falls, South Dakota, 57105

Available

Novartis Investigative Site
Chattanooga, Tennessee, 37404

Available

Novartis Investigative Site
Jackson, Tennessee, 38305

Available

Novartis Investigative Site
Memphis, Tennessee, 38103

Available

Novartis Investigative Site
Memphis, Tennessee, 38104

Available

Novartis Investigative Site
Memphis, Tennessee, 38157

Available

Novartis Investigative Site
Dallas, Texas, 75246

Available

Novartis Investigative Site
Galveston, Texas, 77555-0783

Available

Novartis Investigative Site
Houston, Texas, 77025

Available

Novartis Investigative Site
McKinney, Texas, 75069

Available

Novartis Investigative Site
San Antonio, Texas, 78229-4404

Available

Novartis Investigative Site
San Antonio, Texas, 78229

Available

Novartis Investigative Site
San Antonio, Texas, 78284

Available

Novartis Investigative Site
The Woodlands, Texas, 77385

Available

Novartis Investigative Site
Tyler, Texas, 75708

Available

Novartis Investigative Site
Salt Lake City, Utah, 84108

Available

Novartis Investigative Site
Salt Lake City, Utah, 84132

Available

Novartis Investigative Site
Annandale, Virginia, 22003-7360

Available

Novartis Investigative Site
Annandale, Virginia, 22003

Available

Novartis Investigative Site
Arlington, Virginia, 22205

Available

Novartis Investigative Site
Charlottesville, Virginia, 22908-0334

Available

Novartis Investigative Site
Charlottesville, Virginia, 22911

Available

Novartis Investigative Site
Portsmouth, Virginia, 23708

Available

Novartis Investigative Site
Richmond, Virginia, 23298

Available

Novartis Investigative Site
Salem, Virginia, 24153

Available

Novartis Investigative Site
Everett, Washington, 98201

Available

Novartis Investigative Site
Kirkland, Washington, 98034

Available

Novartis Investigative Site
Seattle, Washington, 98108

Available

Novartis Investigative Site
Seattle, Washington, 98109

Available

Novartis Investigative Site
Tacoma, Washington, 98405

Available

Novartis Investigative Site
Morgantown, West Virginia, 26506

Available

Novartis Investigative Site
Milwaukee, Wisconsin, 53226

Available

Novartis Investigative Site
Milwaukee, Wisconsin, 55902

Available

Contacts

Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com

Novartis Pharmaceuticals
+41613241111

Novartis Pharmaceuticals
NCT Number
MeSH Terms
Infection
Clofazimine
Intervention Name
Lamprene®/Clofazimine