At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - STEP 1
In Brief
A clinical study evaluating Letermovir for Pregnant Women Undergoing TOP and TOP - Failed Attempted Termination of Pregnancy. Completed, enrolled 7 participants across 1 site.
Detailed Summary
In the model of the perfused cotyledon, Letermovir crosses the placenta to reach appropriate fetal concentration. The cotyledon model can only be performed in the third trimester placenta. Although it is probable that the transplacental passage in the second trimester is in the same range than the one found in the 2th trimester, it needs to be confirmed. The study will be divided in 2 steps: step 1 will study the Letermovir transplacental transfer in the second trimester and step 2 will test the efficacy of letermovir to inhibit replication in infected fetuses. Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester Primary end point: Concentrations reached in fetal blood relative to EC50 of letermovir.
Study Details
Timeline
Interventions
Each patient will receive 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP. 5 women will receive 240 mg. 5 women will receive 480 mg.