EUCTR2017-002047-15-DE进行中（未招募）1 期
A multicenter, randomized, patient, investigator and sponsor blinded, placebo-controlled phase II study to evaluate the efficacy and safety of CSJ148 in pregnant women with primary HCMV infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Pregnant women = 18 years of age with primary HCMV infection occurring between 6 and 24 weeks of gestation
- •3. Ability to receive study drug within 6 weeks of the presumed onset of primary maternal infection.
- •4. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Confirmed or suspected fetal HCMV infection, defined as positive HCMV DNA in amniotic fluid or fetal ultrasound abnormalities suggestive of fetal
- •HCMV disease.
- •2. Prior treatment with any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3 gm/day oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin (>500 mg/kg), or any other medication with anti-HCMV activity.
- •3. Any surgical or medical condition (other than pregnancy) which might increase the risk for thrombotic events if the patient is given immunoglobulins.
- •These conditions include cryoglobulinemia, monoclonal gammopathies, and hypertriglyceridemia (fasting level >1000 mg/dL). The investigator should
- •make this determination based on the patient’s medical history and laboratory data.
- •4. History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
- •5. Patient request for medical interruption or termination of pregnancy before inclusion.
- •6. Any surgical or medical condition which may jeopardize the patient or fetus in case of participation in the study. The investigator should make this
- •determination in consideration of the patient’s obstetrical history.
- •7. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- •8. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •9. Body weight > 100 kilograms.
研究者
相似试验
招募中
不适用
Comparison of hemostatic agent to suture in terms of hemostatic function and preservation of ovarian functioDiseases of The genitoruinary systemKCT0005586Seoul National University Hospital90
进行中（未招募）
1 期
Efficacy, safety, tolerability, and pharmacokinetics of MIJ821 inpatients with treatment-resistant depressioEUCTR2018-003002-12-ESovartis Farmacéutica, S.A.70
进行中（未招募）
不适用
A clinical trial for the comparison of two anaesthetic creams.Pain related to the cannulation of arteriovenous fistula cannulation in haemodialysis patients.EUCTR2012-004993-25-GRVerisfield (UK) Ltd
进行中（未招募）
1 期
lcerative colitisMild to moderate ulcerative colitisMedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-003113-34-DEovartis Pharma AG45
进行中（未招募）
1 期
Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitisEUCTR2019-003113-34-HUovartis Pharma AG45