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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Withdrawn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
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

    First Posted
    November 28, 2017
    Last Updated
    October 5, 2018
    Sponsor
    Novartis Pharmaceuticals
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    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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