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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Withdrawn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

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:

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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