Pulmonary Multidrug-resistant Tuberculosis (MDR TB) MedDRA version: 9.1 Level: LLT Classification code 10037440 Term: Pulmonary tuberculosis
Conditions
Sponsors
Otsuka Pharmaceutical Development and Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provide written, informed consent prior to all trial-related procedures 2) Male or female patients aged between 18 and 64 years, inclusive, at the time of enrollment into the 242-07-204 trial. Patients who were 64 years at the time of 204 enrollment and who are now 65 years, are eligible for this trial. 3) Patients who have completed trial 242-07-204. 4) Patients judged by the investigator to have the potential for clinical benefit from OPC-67683 exposure. 5) Able to produce sputum for mycobacterial culture or able to obtain sputum produced through induction. 6) Female patients of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control (for example, two of the following precautions: tubal ligation, vaginal diaphragm, intrauterine device, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate) throughout the participation in the trial and for 22 weeks after last dose. 7) Male patients must agree to use an adequate method of contraception (double barrier) throughout the participation in the trial and for 30weeks after last dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Greater than 30 days has elapsed from the patient’s date of completion in the 242- 07-204 trial or greater than 30 days has elapsed since the patient’s trial investigator’s site was initiated in this trial, whichever is later. 2) A history of allergy to any nitro-imidazoles or nitro-imidazole derivates at any time. 3) Use of the medications in Section 4.1 including: use of amiodarone at any time during the previous 12 months, use of other anti-arrhthymics for the previous 30 days, and use of certain other medications, including certain anti-depressants, anti-histamines, and macrolides, for the previous 14 days. 4) Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels =265 µmol/L or hepatic impairment characterized by ALT and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory reference range from the screening lab results. 5) Current clinically relevant changes in the ECG (between Trial 204 day 56 assessment and baseline) such as any atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in both male and female patients), or the QTcF interval over 450 msec in male patients and 470 msec in female patients. 6) Current clinically relevant cardiovascular disorder such as heart failure, coronary artery disease, uncontrolled or poorly controlled hypertension, arrhythmia, tachyarrhythmia or status after myocardial infarction. 7) Any patients with known or reported significant psychiatric history. 8) For patients with HIV infection, CD4 cell count < 350/mm3 or on treatment with anti-retroviral medication for HIV infection. 9) Karnofsky score < 50% while hospitalized and <60% while not hospitalized. 10) Any current diseases or conditions in which the use of nitro-imidazoles or nitroimidazole derivates is contra-indicated. 11) Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). 12) Known or suspected alcohol abuse, that is, abuse sufficient enough to compromise the safety or cooperation of the patient in the opinion of the investigator. 13) Administered an IMP within 1-month prior to Visit 1 other than OPC-67683 given as IMP in trial 242-07-204. 14) Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the informed consent form. 15) Recent use of methadone, benzodiazepines, cocaine, amphetamine/metamphetamine, tetrahydrocannabinol, barbiturates, and opiates as determined by a urine drug screen, unless evidence is provided that the positive drug screen is the result of authorized medications or products prescribed by a physician for a non-abuse related indication. 16) Any disorder that in the judgment of the investigator makes the patient not a good candidate for the trial or may prevent the patient from reliably participating in the entire course of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to provide extended safety and tolerability data for MDR TB patients from longer-term exposure with OPC-67683 up to 6 additional months beyond exposure in 242-07-204.;Secondary Objective: The secondary objective of this trial is to evaluate efficacy of OPC-67683 administered as either 100 mg BID (twice daily) with an option to titrate to 200 mg BID orally administered in combination with Optimized Background Treatment Regimen (OBR) for up to 6 months of exposure in patients who have completed the 242-07-204 trial. Also, this trial will provide additional access or first time access (for patients who received placebo) to OPC-67683 for patients who have completed the 242-07-204 trial and who may continue to receive clinical benefit from OPC-67683 exposure;Primary end point(s): • Vital signs (blood pressure, heart rate, body temperature and body weight). • Standard 12-lead ECG. • Hematology, chemistry, and urinalysis • Audiometry • Visual acuity • Neurological and psychiatric assessments; please refer to the trial operations manual for details on the neurological and psychiatric assessments to be performed. • Coagulation (PT and aPTT) • Cortisol • Thyroid function tests • Concomitant medication usage • AEs and IREs, as observed by the investigator or reported by the patient | — |
Countries
Estonia, Latvia
Outcome results
None listed