EUCTR2013-000161-36-ES进行中（未招募）不适用
Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267) - Phase 2 Study of Posaconazole in Chagas Disease
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.,0 个研究点目标入组 160 人开始时间: 2013年6月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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. Each subject must be 18 to < or = to 50 years of age, of either sex and of any race, weighting > or = to 60 kg, and willing to adhere to visit schedule and study procedures.
- •2. Each subject must have a positive serology result for T. cruzi on any 2 of 3 of the following tests: IFA, IHA, or ELISA (testing results within the past 10 years).
- •3. Each subject must have a positive qualitative PCR for T. cruzi.
- •4. Each subject must have a normal 12-lead ECG, or it must be clinically insignificant.
- •5. Each subject must have a normal 2-D echocardiogram, or it must be clinically insignificant.
- •6. Each subject must have no evidence of ventricular tachycardia on a 24-hr Holter monitoring.
- •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 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject must not weigh less than 60 kg.
- •2. Female subjects must not be breastfeeding, pregnant, or planning pregnancy.
- •3. Subjects must not be immunodeficient or immunosuppressed.
- •4. Subjects must not have a history of megacolon with obstipation or megaesophagus with severe swallowing impairment.
- •5. Subjects must not have previously received benznidazole or nifurtimox.
- •6. Subjects must not be a family member of a participating subject, or reside in the same household as a participating subject.
- •7. Subjects must not have AST or ALT levels greater than 2.5 times ULN at screening.
- •8. Subjects must not have serum creatinine >2.5 mg/dL or 200 micromoles at screening.
- •9. Subjects must not have a history of severe alcohol abuse within 2 years from screening.
- •10. Subjects must not be taking any prohibited medications.
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