JPRN-jRCT2080223168已完成3 期
Phase III Study of AK-120 in Patients with Recurrent Herpes Simplex
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 531
研究概览
简要总结
The superiority of the FCV group to the placebo group was verified for the primary endpoint. The results from the secondary endpoints supported the results from the primary endpoint, confirming the efficacy of early short-duration treatment with FCV for recurrent herpes simplex. In terms of safety, all adverse events that occurred were mild in severity, and there were no clinically significant adverse events associated with the administration of FCV.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •Patients with Recurrent Herpes Simplex
排除标准
- •(1)Patients diagnosed with immunodeficiency or immunocompromised function (such as patients with congenital immunodeficiency, AIDS patients, patients with HIV infection)
- •(2)Patients who have received organ transplants or bone marrow transplants
- •(3)Patients with a history of renal impairment, patients with potential renal impairment, or patients with renal impairment
- •(4)Patients with any disorders that should not be enrolled in the study such as;
- •-severe cardiac disorders
- •-severe hepatic disorders
- •-severe pulmonary disorders
- •-severe gastrointestinal disorders
- •-severe blood disorders
- •(5)Pregnant women, women who may be pregnant, lactating women or women who wish to become pregnant or women who are unwilling to use a suitable method of contraception as directed by the principal investigator or sub-investigator
研究者
相似试验
未知
3 期
Phase 3 clinical study of AK-120 in patients with herpes zosterHerpes zosterJPRN-jRCT2080220058ASAHIKASEI PHARMA CORPORATIO
进行中（未招募）
3 期
Phase III Study of AK112 for NSCLC PatientsNon-Squamous Non-small Cell Lung CancerNCT06396065Summit Therapeutics420
进行中（未招募）
3 期
Phase 3 Clinical Study of AK112 for NSCLC PatientsNon-Squamous Non-small Cell Lung CancerNCT05184712Akeso322
已完成
1 期
A Study to Assess the Effect of AK3280 on Renal Function in Healthy SubjectsHealthyNCT03990688Shanghai Ark Biopharmaceutical Co., Ltd.48
招募中
1 期
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin LymphomaClassic Hodgkin LymphomaNCT06642792Akeso280