EUCTR2008-005107-26-EE进行中（未招募）不适用
A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis
Otsuka Pharmaceutical Development and Commercialization, Inc.0 个研究点目标入组 430 人开始时间: 2009年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 who meet the definition of sputum culture conversion as defined within the 242-07-204 trial, or patients who have confirmed susceptibility to OPC-67683 as determined by drug susceptibility testing result, or patients who have presumed susceptibility to OPC-67683 and a pending DST result. If DST results indicate resistance to OPC-67683 once available, then the patient must be withdrawn from the trial at the time the resistant DST result is received. Requirements for withdrawal are outlined in Section 3.8.
- •5) Patients judged by the investigator to have the potential for clinical benefit from OPC-67683 exposure.
- •6) Able to produce sputum for mycobacterial culture or able to obtain sputum produced through induction.
- •7) 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.
- •8) 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
排除标准
- •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
- •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.
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