Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction
研究概览
简要总结
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)
- •Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
- •Must have a normal 12-lead electrocardiogram (ECG)
- •Must have a normal 2-D echocardiogram
- •Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
- •Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
- •Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug
排除标准
- •Are breastfeeding, pregnant, or planning to become pregnant
- •Body weight <60 kg
- •Have an immunodeficiency or are immunosuppressed
- •History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
- •Have previously received treatment with benznidazole or nifurtimox
- •Known allergy/sensitivity to azoles
- •Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
- •Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening
- •Has a history of severe alcohol abuse within two years from Screening
- •Is taking any of the prohibited medication
研究组 & 干预措施
Posaconazole
Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days
干预措施: Posaconazole (Drug)
Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days
干预措施: Placebo for posaconazole (Drug)
Posaconazole + Benznidazole
Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
干预措施: Posaconazole (Drug)
Posaconazole + Benznidazole
Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
干预措施: Benznidazole (Drug)
Benznidazole + Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
干预措施: Placebo for posaconazole (Drug)
Benznidazole + Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
干预措施: Benznidazole (Drug)
结局指标
主要结局
Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction
时间窗: Day 180
Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.
次要结局
未报告次要终点