EUCTR2013-003341-41-ES进行中（未招募）不适用
Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of CR8020 and CR6261 in hospitalized patients with influenza A infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 296
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
- All
入选标准
- •1)Subject must be a male or a female 18 years of age or older
- •2)Subject requires hospitalization.
- •3)Each subject or his or her legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent may be given for an unconscious/incapacitated subject by a legally acceptable representative, according to local regulatory and ethical practice using a subject information sheet and informed consent form approved by the responsible Ethics Committee. When a subject is no longer unconscious/incapacitated, informed consent or assent (if consent not feasible) will be obtained from the subject at that time.
- •4)Subject must have a diagnosis of influenza A by rapid immunoassay, PCR or other approved test capable of typing influenza A and B (subtyping by PCR if available is preferable)
- •5) A woman must be either:
- •?Not be of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months); permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
- •?Of childbearing potential and agrees to practice two forms of highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g. established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject) for the duration of the study
- •Note: If the childbearing potential changes after start of the study (e.g. woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must agree to begin two highly effective methods of birth control, as described above for the duration of the study.
- •This screening assessment will not apply to unconscious/incapacitated subjects.
- •6)A woman of childbearing potential must have a negative serum (Beta human chorionic gonadotropin [Beta-hCG]) at screening.
- •7)A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. This screening assessment will not apply to unconscious/incapacitated subjects.
- •8)Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. This screening assessment will not apply to unconscious/incapacitated subjects. When a subject is no longer unconscious/incapacitated, this criterion will be assessed at that time.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 178
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
排除标准
- •1)Subject is a female who is pregnant or breastfeeding.
- •2)Subject undergoing peritoneal dialysis, hemodialysis or hemofiltration.
- •3)Subject has presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
- •4)Subject has prior treatment with an experimental mAb; or receipt of IgG within 3 months or on chronic mAb treatment prior to enrollment.
- •5)Subject has known or suspected hypersensitivity to any of the CR8020 or CR6261 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20).
- •6)Subject received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment, is currently enrolled in an interventional investigational study, or is an employee of the investigational site.
研究者
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