Clinical trial NCT03369912: A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
Official title: A Multicenter, Randomized, Patient, Investigator and Sponsor Blinded, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of CSJ148 in Pregnant Women With Primary HCMV Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: HCMV Infection
Keywords: Safety, efficacy
pregnant women
CSJ148
HCMV infection
congenital HCMV
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Intervention model description: This is a randomized, patient, investigator and sponsor blinded, placebo-controlled study in pregnant women with primary HCMV infection. This study is a non-confirmatory trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Pregnant women ≥ 18 years of age with primary HCMV infection occurring between 6 and 24 weeks of gestation
3. Ability to receive study drug within 6 weeks of the presumed onset of primary maternal infection.
4. Able to communicate well with the investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Confirmed or suspected fetal HCMV infection, defined as positive HCMV DNA in amniotic fluid or fetal ultrasound abnormalities suggestive of fetal HCMV disease.
2. Prior treatment with any of the following within 30 days prior to enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (\>25 mg/kg/day IV), valacyclovir (\>3 gm/day oral), famciclovir (\>1500 mg/day oral), HCMV immune globulin, immune globulin (\>500 mg/kg), or any other medication with anti-HCMV activity.
3. Any surgical or medical condition (other than pregnancy) which might increase the risk for thrombotic events if the patient is given immune-globulins. These conditions include cryoglobulinemia, monoclonal gammopathies, and hypertriglyceridemia (fasting level \>1000 mg/dL). The investigator should make this determination based on the patient's medical history and laboratory data.
4. History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
5. Patient request for medical interruption or termination of pregnancy before inclusion.
6. Any surgical or medical condition which may jeopardize the patient or fetus in case of participation in the study. The investigator should make this determination in consideration of the patient's obstetrical history.
7. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
8. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
9. Body weight \> 100 kilograms.

Primary outcomes:
measure: Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection
timeFrame: Day 218
Secondary outcomes:
measure: Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)
timeFrame: Day 218
measure: Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth
timeFrame: Baseline, Day 218
measure: Pharmacokinetic concentration data of CSJ148
timeFrame: Days 1,29,57,85,218,141,169, 197, 218
measure: CSJ148 concentration in cord blood
timeFrame: Day 218
measure: Immunogenicity of CSJ148 in pregnant women
timeFrame: Days 1,29,57,85,218,141,169, 197, 218
measure: Immunogenicity of CSJ148 in cord blood
timeFrame: Day 218
measure: CSJ148 concentration in amniotic fluid
timeFrame: Day 218
Other outcomes:
Locations:
Study officials:
References: