The purpose of the study is to evaluate the feasibility of using CSJ148 to prevent congenital human cytomegalovirus (HCMV) in pregnant women with primary HCMV infection.
This is a randomized, patient, investigator and sponsor blinded, placebo-controlled study in pregnant women with primary HCMV infection. The study has three periods: (I) screening (II) double-blinded placebo-controlled treatment and (III) post-delivery follow-up of women and neonates/infants. Pregnant women with confirmed primary HCMV infection will participate in periods I and II. Mothers and neonates/infants born to mothers enrolled in the study will participate in period III.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
TRIPLE
Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection
To assess the efficacy of CSJ148 on reducing intrauterine HCMV transmission compared to placebo
Time frame: Day 218
Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)
Change in symptomatic HCMV disease, assessed by event rates in patients vs controls
Time frame: Day 218
Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth
Change in HCMV urine viral load in neonates at birth
Time frame: Baseline, Day 218
Pharmacokinetic concentration data of CSJ148
Concentration of CSJ148 (LJP538 and LJP539) in serum
Time frame: Days 1,29,57,85,218,141,169, 197, 218
CSJ148 concentration in cord blood
Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood
Time frame: Day 218
Immunogenicity of CSJ148 in pregnant women
Detection of anti-LJP538 and anti-LJP539 antibodies in serum at selected timepoints
Time frame: Days 1,29,57,85,218,141,169, 197, 218
Immunogenicity of CSJ148 in cord blood
Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood
Time frame: Day 218
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CSJ148 concentration in amniotic fluid
Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid
Time frame: Day 218