Pregnant women with primary HCMV infection.
Conditions
Interventions
Trade Name: CYTOTECT BIOTEST*EV 20ML 1000U
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cytomegalovirus immunoglobulin
Concentration unit: mg/ml milligram(s)/millilitre
Concentratio
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: pregnant women, >/= 18 years, primary HCMV infection at 5-26 week of gestation, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)multiple pregnancy, 2)history of HIV infection, 3) known immunodeficiency or immunosuppression, 4) congenital or required auotimmune desease 5) known intollerance to proteins of human origin, 6) hypersensitivity to human immunoglobulin, 7) suspected serious organic or psychiatric desease 8) not willing to give informed consent, not willing to give consent to treatment of personal pseudonymised data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the efficacy of HCMV-specific hyperimmune globulin in pregnant women with primary HCMV infection for the prevention of intrauterine transmission.;Secondary Objective: 1) evaluation and comparison of virus-specific virological, serological and cell-mediated immunological parameters in pregnant women treated with Cytotect or NaCl; 2) evaluation and comparison of virological and histological findings in placentas of pregnant women treated with Cytotect or NaCl; 3) clinical outcome of congenital HCMV infection at birth; 4) safety of Cytotect.;Primary end point(s): Number of HCMV-infected newborns or fetuses. | — |
Countries
Italy
Outcome results
None listed