Ensayos clínicos

Inclusion Criteria:

• Male or female patients.
• 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.
• Examples of highly effective contraception methods include, but are not limited to:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject);
  • Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, postovulation methods) and withdrawal are not acceptable methods of contraception;
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level ssessment;
  • Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with oral or injected or implanted hormonal contraception or intra-uterine device or with spermicidal foam/gel/film/ cream/vaginal suppository;
  • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
• Women of child-bearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

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.