PER-128-09已完成未知
A Phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB.
Janssen Infectious Diseases - Diagnostics BVBA,0 个研究点目标入组 19 人开始时间: 2010年3月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
入选标准
- •Subjects men or women at least 18 years of age. Women can participate if they are not potentially fertile, if they are using effective birth control methods and are willing to continue using birth control methods in accordance with Section 5.2.4 throughout the treatment for MDR-TB, or without are not heterosexually active or are willing to practice sexual abstinence throughout the treatment for MDR-TB.
- •Confirmed MDR-TB pulmonary infection, which is defined as an infection by a strain of M. tuberculosis resistant to at least RMP and INH proven by a previous analysis carried out in a center for the treatment of TB within the previous six months. Subjects infected with XDR-TB may also enter the study.
- •Positive for acid-resistant bacilli (AFB) on direct smear examination of the expectorated sputum sample (> 1 + positive smear).
- •HIV positive or negative status documented in the selection or within the month prior to the start of the study (by means of enzymatic immunoabsorption tests [ELISA] and / or Western Blot).
- •Subjects who have signed the ICF voluntarily before the first activity related to the study.
- •Subjects who can meet the requirements of the protocol.
- •Subjects willing to comply with the NTP treatment guidelines.
排除标准
- •Subjects having a known or suspected hypersensitivity or serious adverse reaction to TMC207.
- •Subjects using disallowed concomitant therapy as specified in Protocol Section 5.3.11.
- •Subjects having a current or past history of alcohol and/or drug use that, in the investigator´s opinion, would compromise the subject´s safety or compliance to the study protocol procedures.
- •HIV infected subjects having a CD4+ count <250 cells/µL.
- •Subjects with significant cardiac arrhythmia requiring medication.
- •Subjects with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection.
- •Having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start.
- •Presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult or otherwise make the subject a poor candidate for a clinical trial.
- •Subjects with the following QT/QTc interval characteristics at screening: a. A marked prolongation of QT/QTc interval, e.g., confirmed demonstration of QTcF (Fridericia correction) interval > 450 ms at screening; b. A history of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of Long QT Syndrome; c. The use of concomitant medications that prolong the QT/QTc interval listed as disallowed medication in Protocol Section 5.3.11; d. Pathological Q-waves (defined as > 40 ms or depth > 0.4-0.5 mV); e. Evidence of ventricular pre-excitation; f. ECG evidence of complete or incomplete left bundle branch block or right bundle branch block; g. Evidence of second or third degree heart block; h. Intraventricular conduction delay with QRS duration > 120 ms; i. Bradycardia as defined by sinus rate < 50 bpm.
- •Subjects with the following toxicities at screening as defined by the enhanced Division of Microbiology and Infectious Diseases (DMID) adult toxicity table (November 2007): - Creatinine grade 2 or greater (> 1.5 times upper limit of normal [ULN]); - Lipase grade 3 or greater (> 2.0 x ULN); - Hemoglobin grade 4 (< 6.5 g/dL) except after discussion with the Medical Leader; - Aspartate aminotransferase (AST) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Alanine aminotransferase (ALT) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Alkaline phosphatase (ALP) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (= 3.0 x ULN) must be discussed with Medical Leader; - Total bilirubin grade 3 or greater (> 2.00 x ULN, or > 1.50 x ULN when accompanied by any increase in other liver function test) to be excluded, grade 2 (> 1.50 x ULN, or > 1.25 x ULN when accompanied by any increase in other liver function test) must be discussed with the Medical Leader;
- •Women who are pregnant or breastfeeding.
- •Subjects who have previously received treatment with TMC207 as part of a clinical trial.
- •Subjects having AIDS defining illnesses other than TB, or showing severe symptoms of HIV infection that would make the subject a poor candidate for participation in the trial.
- •Subjects who, upon the evaluation of their pulmonary disease, will require surgical procedure for management of their TB infection within the 24-week treatment period with TMC207.
研究者
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