A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03369912|
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|HCMV Infection||Biological: CSJ148 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 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)|
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.
|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 :||October 23, 2018|
|Estimated Primary Completion Date :||November 15, 2022|
|Estimated Study Completion Date :||November 15, 2022|
Placebo Comparator: Placebo
- 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
- 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
- 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
- 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
- CSJ148 concentration in cord blood [ Time Frame: Day 218 ]Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood
- 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
- Immunogenicity of CSJ148 in cord blood [ Time Frame: Day 218 ]Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood
- CSJ148 concentration in amniotic fluid [ Time Frame: Day 218 ]Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid
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
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|