NCT01096576已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Safety and tolerability: Adverse events, laboratory parameters, vital signs
研究概览
简要总结
This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200
研究设计
- 研究类型
- Interventional
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male patients, 18-65 years of age
- •dengue virus infection (confirmed by NS1 strip test) with symptom onset </=48 hours before first study drug administration
- •patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
- •BMI between 18 and 35
排除标准
- •positive test at screening for HIV using point of care test, or known HIV infection
- •history of any disease known to cause significant alteration in immunologic function or autoimmune disease
- •patients taking steroid or other immuno-suppressive therapies
- •positive test for drugs of abuse or alcohol using point of care test
- •clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome
研究组 & 干预措施
A
Experimental
干预措施: balapiravir [RO4588161] (Drug)
B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability: Adverse events, laboratory parameters, vital signs
时间窗: days 1-7 and on follow-up days 14, 28 and 84
次要结局
- Quality of life(assessments days 1, 3, 5, 7, 14, 28 and 84)
- Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites(multiple sampling days 1 and 5)
- Body temperature(days 1-7 and on follow-up days 14, 28 and 84)
- Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)(days 1-7, and on follow-up days 14, 28 and 84)
- Viral load(days 1-7 and 14)
- Immunological parameters: plasma samples (cytokines)(days 1-7 and 14)
研究者
相似试验
已完成
1 期
A Study of Single Dose RO6811135 in Healthy VolunteersHealthy VolunteerNCT01676584Hoffmann-La Roche56
已完成
1 期
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.Diabetes Mellitus Type 2NCT01017302Hoffmann-La Roche32
已完成
1 期
A Study of RG1662 in Individuals With Down SyndromeDown SyndromeNCT01436955Hoffmann-La Roche35
已完成
不适用
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast CancerBreast CancerNCT01358877Hoffmann-La Roche4,804
撤回
2 期
A Study of RO5036505 in Patients With Moderate to Severe AsthmaAsthmaNCT00967590Hoffmann-La Roche