CLINICAL TRIAL, PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED WITH INTRAVENOUS IMMUNOGLOBULIN HUMAN FOR THE TREATMENT OF REPEAT ABORTION WITH IMMUNE ETIOLOGY - INMUNOGEST

silvia sanchez ramon0 个研究点开始时间: 2016年4月20日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•Signed informed consent before any assessment and intervention on the patient.
•Women with three consecutive spontaneous abortions, 18 to 37 years of age, inclusive
•Circulating cytotoxic NK cells (CD3-CD56 + CD16 +) with a value of 13% of total lymphocytes in 35 years or more and less than 22% in 35 years or NKT cells ?10% of total lymphocytes .
•Weight Between 40 kg and 90 kg, inclusive.
•Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
•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 66
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Medication use prohibited in the study.
•Known hypersensitivity to immunoglobulins
•Recent clinically significant bacterial infection.
•Immunodeficiency diseases, including HIV.
•Hepatitis B or C and / or positive hepatitis B surface antigen (HBsAg) or hepatitis C test at screening, at the present time.
•Alcohol abuse at present or during the previous 12 months.
•Participation in any clinical trial with an experimental drug or affect the ability or maintenance of conception in the 4 weeks prior to the first dose.
•Any other condition in the investigator's opinion may make the patient inappropriate for entry into the study.

发起方

silvia sanchez ramon