PACTR202010817169062已完成2 期
Pharmacokinetics, tolerability and safety of favipiravir compared to ribavirin for the treatment of Lassa Fever: A randomized controlled open label phase II clinical trial
Bernhard Nocht Institute for Tropical Medicine0 个研究点目标入组 40 人开始时间: 2019年6月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Age = 18 years
- •Lassa fever confirmed by PCR
- •Written informed consent
排除标准
- •Inability to give consent (e.g. unconscious patients/ cognitively impaired patients)
- •Women who plan to get pregnant within the upcoming 6 months
- •Severe malnutrition (BMI<16)
- •Pregnancy/lactation (evidenced by negative urine pregnancy test in women of child-bearing potential)
- •Known intolerance to ribavirin or favipiravir
- •History of hemoglobinopathies (i.e., sickle-cell anaemia or thalassemia major) and/or haemophilia
- •Organ failure as evidenced by:
- •oCreatinine = 3x ULN
- •oALT/ AST > 150 IU/l
- •oACVPU score = V or P or U (corresponds to GCS = 12)
- •oSevere central nervous system features (e.g. seizures, restlessness, confusion or coma)
- •oO2 Saturation < 90%
- •oHematocrit <30 %
- •oSevere anaemia requiring blood transfusion
- •Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- •Patients who already received ribavirin or favipiravir within the preceding 7 days
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