A phase II study to evaluate CSJ148 in pregnant women with primary HCMV infectio

Phase 1

• Conditions: Congenital human cytomegalovirus (HCMV) infection in pregnant women; MedDRA version: 20.0Level: LLTClassification code 10010420Term: Congenital CMV infectionSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-002047-15-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 immunoglobulins.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of CSJ148 on reducing intrauterine HCMV transmission compared to placebo;Secondary Objective: - To assess the safety and tolerability of CSJ148 when administered to pregnant women with primary HCMV infection<br>- Among neonates born with congenital HCMV infection, assess if CSJ148 can reduce symptomatic congenital HCMV disease compared to placebo<br>- To assess if CSJ148 can reduce neonatal HCMV urine viral load at birth compared to placebo<br>- To assess the pharmacokinetics of CSJ148 in pregnant women<br>- To assess CSJ148 drug exposure in cord blood<br>- To assess the immunogenicity of CSJ148 in pregnant women<br>- To assess the immunogenicity of CSJ148 in cord blood;Primary end point(s): Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection;Timepoint(s) of evaluation of this end point: Days 1,29,57,85,218,141,169, 197, 218

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo) (Time point: Day 218)<br>- Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth (Time point:Baseline, Day 218)<br>- Pharmacokinetic plasma concentration data of CSJ148 (Time point: Days 1,29,57,85,218,141,169, 197, 218)<br>- CSJ148 concentration in cord blood (Time point: Day 218)<br>- Immunogenicity of CSJ148 in pregnant women (Time point: Days 1,29,57,85,218,141,169, 197, 218)<br>- Immunogenicity of CSJ148 in cord blood (Time point: Day 218)<br>- CSJ148 concentration in amniotic fluid (Time point: Day 218);Timepoint(s) of evaluation of this end point: As defined above in Section E.5.2