Valaciclovir for Primary cytomegalovirus (CMV) infection

Stratification factors

• Estimated time of infection (periconceptional vs first trimester) based on CMV IgG avidity

Inclusion criteria

• {"criterion_text":"- Pregnant women aged 18 years and older."}
• {"criterion_text":"- The presence of IgG antibodies to CMV, whose previous result in the current pregnancy was negative (seroconversion) and/or antibodies to CMV in the IgM and IgG classes with low avidity (below 50% or index marked by the laboratory as low avidity)"}
• {"criterion_text":"- The presence of the above-mentioned antibodies before 16 weeks of pregnancy."}
• {"criterion_text":"- Giving written informed consent to participate in the study."}
• {"criterion_text":"- Confirmed singleton or twin pregnancy."}

Exclusion criteria

• {"criterion_text":"- Pregnant women aged under 18."}
• {"criterion_text":"- Known allergy or hypersensitivity to valacyclovir or acyclovir."}
• {"criterion_text":"- Mental disorder or intellectual disability."}
• {"criterion_text":"- Renal disease, abnormal liver function parameters, chronic diseases."}
• {"criterion_text":"- A patient who participated in any other clinical trial 3 months before enrollment in the study."}
• {"criterion_text":"- Positive result of screening tests for viral diseases performed routinely in accordance with the standard of perinatal care (HBV, HIV, HCV), active/recent TOXO infection, WR."}
• {"criterion_text":"- Patients not vaccinated against tuberculosis."}
• {"criterion_text":"- Contraindications to magnetic resonance imaging."}
• {"criterion_text":"- Multiple pregnancy (more than twins)."}

Primary endpoints

• {"endpoint_text":"- Percentage of newborns in whom CMV DNA was not detected in the amniotic fluid in the compared groups (assessed at visits 4 and 5).","definition_or_measurement_approach":"Assessed by detection of CMV DNA in amniotic fluid at visits 4 and 5; outcome defined as percentage of newborns with undetectable CMV DNA in amniotic fluid."}

Secondary endpoints

• {"endpoint_text":"- CMV DNA replication level in fetal blood according to CMV DNA replication level in maternal blood (assessed at visit 5).","definition_or_measurement_approach":"Measurement of CMV DNA replication levels in fetal and maternal blood at visit 5; comparison of fetal vs maternal replication levels."}
• {"endpoint_text":"- Platelet count in the fetus depending on the dose of drug used (assessed at visit 5)","definition_or_measurement_approach":"Fetal platelet count measured/assessed at visit 5 and analysed by treatment dose group."}
• {"endpoint_text":"- Percentage of missed doses of a drug in the compared groups (assessed by interview at each visit, from 1 to 5).","definition_or_measurement_approach":"Assessed by participant interview at each visit (visits 1 to 5); outcome is percentage of missed doses."}
• {"endpoint_text":"- The percentage of newborns in whom the presence of CMV DNA in the amniotic fluid was not detected in the compared groups depending on the level of virus replication in the amniotic fluid (assessed on visits 4 and 5).","definition_or_measurement_approach":"Assessment at visits 4 and 5 of CMV DNA in amniotic fluid; analysis of percentage negative by level of viral replication in amniotic fluid."}
• {"endpoint_text":"- Assessment of the frequency of adverse events in the study groups.","definition_or_measurement_approach":"Frequency of adverse events collected and compared between study groups (no further measurement detail provided)."}

Methods

• Prescreening of pregnant women before 10 (±6) weeks of pregnancy including diagnostic CMV testing (CMV IgM and IgG and IgG avidity) for a prescreening cohort of 4,000 patients; target audience: pregnant women in participating Polish sites.

Poland

Earliest CTIS Part Ii Submission Date

19-01-2024

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

781

Number Of Sites

2

Number Of Participants

200

Primary sponsor

Full Name

Instytut Matki I Dziecka

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Contract research organisations

Name

Masha Regulatory Service Anna Jelitto

Responsibilities

sponsorDuties codes: 1,11,12,5,8

Third parties

• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Medicofarma S.A.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Masha Regulatory Service Anna Jelitto","duties_or_roles":"sponsorDuties codes: 1,11,12,5,8","organisation_type":"Industry"}