EUCTR2009-014944-13-LT进行中（未招募）不适用
A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients with Pulmonary Multidrug-Resistant TuberculosisRefractory to Conventional Treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Patients with at least three sputum mycobacterial cultures
- •positive for MTB with in vitro resistance to isoniazid and
- •rifampicin collected at separate timepoints during the
- •previous 270 days (9 months) despite treatment with first
- •and second-line anti-TB drugs, including one culture
- •within the previous 60 days prior to date of screening
- •initiation.
- •Patients with sputum mycobacterial culture positive for
- •MTB with in vitro susceptibility to at least one anti-TB
- •medication within the previous 60 days prior to date of
- •screening initiation.
- •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
- •A history of allergy to any nitro-imidazoles or nitroimidazole
- •Prohibited medications: use of amiodarone for 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.
- •Current clinically relevant changes in the screening ECG
- •such as any atrioventricular (AV) block, prolongation of
- •the QRS complex over 120 milliseconds (in both male and
- •female patients), or of QTcF interval over 450
- •milliseconds in male patients and over 470 milliseconds in
- •female patients.
- •Current clinically relevant cardiovascular disorder such as
- •heart failure, coronary heart disease, uncontrolled or
- •poorly controlled hypertension, arrhythmia,
- •tachyarrhythmia or status after myocardial infarction.
- •For patients with HIV infection, CD4 cell count <
- •350/mm3 or on treatment with anti-retroviral medication
- •for HIV infection.
研究者
相似试验
进行中（未招募）
不适用
A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients with Pulmonary Multidrug-Resistant TuberculosisRefractory to Conventional Treatment.EUCTR2009-014944-13-LVOtsuka Pharmaceutical Development & Commercialization, Inc.30
进行中（未招募）
1 期
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma - N/APatients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinomaMedDRA version: 12.0Level: LLTClassification code 10064467Term: Urothelial carcinomaEUCTR2008-005870-11-NLovartis Pharma Services AG
进行中（未招募）
1 期
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinomaPatients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinomaMedDRA version: 14.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005870-11-GBovartis Pharma Services AG
进行中（未招募）
不适用
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma - N/AEUCTR2008-005870-11-ATovartis Pharma Services AG99
进行中（未招募）
不适用
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma - N/AMedDRA version: 13.1Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinomaEUCTR2008-005870-11-DEovartis Pharma Services AG80