A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection

NCT03369912 | Withdrawn Phase 2 DMC

• 2 other identifiers: CCSJ148X22022017-002047-15
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HCMV Infection

Keywords

Safety, efficacy; pregnant women; CSJ148; HCMV infection; congenital HCMV

Outcome Measures

Primary Outcomes (1)

• 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

  Day 218

Secondary Outcomes (7)

• Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)

  Day 218

• Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth

  Baseline, Day 218

• Pharmacokinetic concentration data of CSJ148

  Days 1,29,57,85,218,141,169, 197, 218

• CSJ148 concentration in cord blood

  Day 218

• Immunogenicity of CSJ148 in pregnant women

  Days 1,29,57,85,218,141,169, 197, 218

Study Arms (2)

Active

EXPERIMENTAL

CSJ148

Biological: CSJ148

Placebo

PLACEBO COMPARATOR

5% dextrose

Other: Placebo

Interventions

CSJ148 BIOLOGICAL

Active

Active

Placebo OTHER

No Drug

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: pregnant Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Confirmed or suspected fetal HCMV infection, defined as positive HCMV DNA in amniotic fluid or fetal ultrasound abnormalities suggestive of fetal HCMV disease.
• 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.
• 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.
• 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.
• 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.
• History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
• Body weight \> 100 kilograms.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a patient, investigator and sponsor-blinded study. Patients, investigators and sponsor will remain blinded to study treatment throughout the study. With the exception of any unblinded site staff identified below, all site staff (including study investigator and study nurse) will be blinded to study treatment throughout the study. Drug product will be supplied in patient specific kits, so an unblinded pharmacist who is independent of the study team will be required in order to maintain the blind. Appropriate measures must be taken by the unblinded pharmacist to ensure that the treatment assignments are concealed from the rest of the site staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 12, 2017
• Study Start: October 23, 2018
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share