recurrent aborption with inmunological etiology MedDRA version: 19.0 Level: LLT Classification code 10072314 Term: Pregnancy loss System Organ Class: 100000004868
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ig IV
CAS Number: Ig IV
Current Sponsor code: Ig IV
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/kg millig
Sponsors
silvia sanchez ramon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that treatment with IVIG in patients with recurrent abortions and expansion of NK and NKT cells in peripheral blood increases the proportion of live births.;Secondary Objective: ? To evaluate the profile of Th1 / Th2 / Th17 / Treg and chemokines in plasma prior to and during treatment with IVIG in patients with recurrent abortions. ? To evaluate the percentage and phenotype of NK cells and T regulatory circulating before and during treatment with IVIG in patients with recurrent abortions. ? To assess the safety of IVIg in patients with recurrent abortions. ? To evaluate the safety of live births to mothers exposed to IVIG. ? To evaluate the quality of life of mothers of newborns alive after IVIG administration.;Primary end point(s): new born number;Timepoint(s) of evaluation of this end point: at the end of the pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of pregnancies achieved 2. Quality of Life 3. Gestation time 4. Proportion of congenital malformations. 5. Rate of postpartum infection 6. Percentile of height, weight and head circumference of the newborn 7. Newborn neurologic development;Timepoint(s) of evaluation of this end point: 3-4 after pregncancy | — |
Countries
Spain
Contacts
Public Contactunidad de inmunología
hospital clinico san carlos
Outcome results
None listed