A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
Primary Purpose
HCMV Infection
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CSJ148
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HCMV Infection focused on measuring Safety, efficacy, pregnant women, CSJ148, HCMV infection, congenital HCMV
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
- Patient request for medical interruption or termination of pregnancy before inclusion.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
CSJ148
5% dextrose
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)
Change in symptomatic HCMV disease, assessed by event rates in patients vs controls
Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth
Change in HCMV urine viral load in neonates at birth
Pharmacokinetic concentration data of CSJ148
Concentration of CSJ148 (LJP538 and LJP539) in serum
CSJ148 concentration in cord blood
Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood
Immunogenicity of CSJ148 in pregnant women
Detection of anti-LJP538 and anti-LJP539 antibodies in serum at selected timepoints
Immunogenicity of CSJ148 in cord blood
Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood
CSJ148 concentration in amniotic fluid
Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid
Full Information
NCT ID
NCT03369912
First Posted
November 28, 2017
Last Updated
October 5, 2018
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03369912
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Company decision to withdraw before study started
Study Start Date
October 23, 2018 (Anticipated)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCMV Infection
Keywords
Safety, efficacy, pregnant women, CSJ148, HCMV infection, congenital HCMV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
CSJ148
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5% dextrose
Intervention Type
Biological
Intervention Name(s)
CSJ148
Intervention Description
Active
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No Drug
Primary Outcome Measure Information:
Title
Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection
Description
To assess the efficacy of CSJ148 on reducing intrauterine HCMV transmission compared to placebo
Time Frame
Day 218
Secondary Outcome Measure Information:
Title
Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)
Description
Change in symptomatic HCMV disease, assessed by event rates in patients vs controls
Time Frame
Day 218
Title
Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth
Description
Change in HCMV urine viral load in neonates at birth
Time Frame
Baseline, Day 218
Title
Pharmacokinetic concentration data of CSJ148
Description
Concentration of CSJ148 (LJP538 and LJP539) in serum
Time Frame
Days 1,29,57,85,218,141,169, 197, 218
Title
CSJ148 concentration in cord blood
Description
Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood
Time Frame
Day 218
Title
Immunogenicity of CSJ148 in pregnant women
Description
Detection of anti-LJP538 and anti-LJP539 antibodies in serum at selected timepoints
Time Frame
Days 1,29,57,85,218,141,169, 197, 218
Title
Immunogenicity of CSJ148 in cord blood
Description
Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood
Time Frame
Day 218
Title
CSJ148 concentration in amniotic fluid
Description
Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid
Time Frame
Day 218
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
History of chronic hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infection. Cured hepatitis C in not considered exclusionary.
Patient request for medical interruption or termination of pregnancy before inclusion.
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
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