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临床试验/JPRN-jRCTs031230591
JPRN-jRCTs031230591招募中Unknown

Study of milk transfer of amenamevir in patients with recurrent herpes simplex during lactation

Murashima Atsuko0 个研究点目标入组 20 人开始时间: 2024年1月24日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
20

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
>= 18age old 至 <= 37age old(—)
性别
Female

入选标准

  • 1) Patients with a previous diagnosis of recurrent herpes simplex
  • 2) Patients with at least 1 recurrence of herpes simplex in the past 1 year
  • 3) Patients who are breast-feeding within 1 year after delivery at the time of consent
  • 4) Patients who are between 18 and 37 years of age at the time of consent
  • 5) Patients weighing between 40 kg and 70 kg at the time of consent
  • 6) Patients who are judged by the principal investigator or a research associate to be able to abstain from breastfeeding for 48 hours after taking AMNV
  • 7) Patients who freely and voluntarily consent to participate in this study in writing.

排除标准

  • 1) Patients who have ingested drugs, foods, or beverages listed in the Contraindications or Precautions section of the AMNV package insert within 14 days prior to obtaining consent
  • 2) Patients requiring dietary restrictions due to comorbidities, etc.
  • 3) Patients on extreme diet restrictions due to dieting, etc.
  • 4) Patients with a history of hypersensitivity to AMNV
  • 5) Patients with diabetes mellitus, hepatitis B or C, tuberculosis, mastitis, comorbidity or history of malignancy
  • 6) Patients with a history of HIV infection or comorbidity or history of AIDS
  • 7) Patients who are pregnant or may become pregnant, or who wish to become pregnant during the study period
  • 8) Other patients deemed ineligible by the principal investigator or subinvestigator.

研究者

发起方
Murashima Atsuko

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