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Trial record 12 of 3982 for:    Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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

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ClinicalTrials.gov Identifier: NCT03369912
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
HCMV Infection Biological: CSJ148 Other: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes 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.

Primary Purpose: Treatment
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
Estimated Study Start Date : September 20, 2018
Estimated Primary Completion Date : October 13, 2022
Estimated Study Completion Date : October 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
CSJ148
Biological: CSJ148
Active

Placebo Comparator: Placebo
5% dextrose
Other: Placebo
No Drug




Primary Outcome Measures :
  1. Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection [ Time Frame: Day 218 ]
    To assess the efficacy of CSJ148 on reducing intrauterine HCMV transmission compared to placebo


Secondary Outcome Measures :
  1. Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo) [ Time Frame: Day 218 ]
    Change in symptomatic HCMV disease, assessed by event rates in patients vs controls

  2. Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth [ Time Frame: Baseline, Day 218 ]
    Change in HCMV urine viral load in neonates at birth

  3. Pharmacokinetic concentration data of CSJ148 [ Time Frame: Days 1,29,57,85,218,141,169, 197, 218 ]
    Concentration of CSJ148 (LJP538 and LJP539) in serum

  4. CSJ148 concentration in cord blood [ Time Frame: Day 218 ]
    Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood

  5. Immunogenicity of CSJ148 in pregnant women [ Time Frame: Days 1,29,57,85,218,141,169, 197, 218 ]
    Detection of anti-LJP538 and anti-LJP539 antibodies in serum at selected timepoints

  6. Immunogenicity of CSJ148 in cord blood [ Time Frame: Day 218 ]
    Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood

  7. CSJ148 concentration in amniotic fluid [ Time Frame: Day 218 ]
    Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant Women
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369912


Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals novartis.email@novartis.com

Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03369912     History of Changes
Other Study ID Numbers: CCSJ148X2202
2017-002047-15 ( EudraCT Number )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Safety, efficacy
pregnant women
CSJ148
HCMV infection
congenital HCMV

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases