HCMV InfectionPhase 2NCT03369912
A Study to Evaluate CSJ148 in Pregnant Women With Primary HCMV Infection
A Phase 2 study testing CSJ148 in people with HCMV Infection, run by Novartis Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HCMV Infection
- What is being tested?
- CSJ148
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2018to 15 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- HCMV Infection
- Being tested
- CSJ148, Placebo
- Keywords
- Safety, efficacy, pregnant women, CSJ148, HCMV infection, congenital HCMV
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSJ148Biological
Active
PlaceboOther
No Drug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | CSJ148 Receives: Biological: CSJ148 |
| Placebo | Placebo comparator | 5% dextrose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 218
Secondary outcomes (7)
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
Measured: Day 218
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
Measured: Baseline, Day 218
Pharmacokinetic concentration data of CSJ148
Concentration of CSJ148 (LJP538 and LJP539) in serum
Measured: Days 1,29,57,85,218,141,169, 197, 218
CSJ148 concentration in cord blood
Concentration of CSJ148 (LJP538 and LJP539) in serum separated from cord blood
Measured: Day 218
Immunogenicity of CSJ148 in pregnant women
Detection of anti-LJP538 and anti-LJP539 antibodies in serum at selected timepoints
Measured: Days 1,29,57,85,218,141,169, 197, 218
Immunogenicity of CSJ148 in cord blood
Detection of anti-LJP538 and anti-LJP539 antibodies in serum from cord blood
Measured: Day 218
CSJ148 concentration in amniotic fluid
Concentration of CSJ148 (LJP538 and LJP539) in amniotic fluid
Measured: Day 218
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start23 Oct 2018 (estimated)
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Why it stopped: Company decision to withdraw before study started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCMV InfectionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369912
- Sponsor's protocol ID
- CCSJ148X2202
- Other IDs
- 2017-002047-15, 2017
- Status last verified
- Oct 2018
- First submitted
- 28 Nov 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03369912
- Acronym / sponsor ID
- CCSJ148X2202
- Conditions
- HCMV Infection
- Keywords
- Safety, efficacy, pregnant women, CSJ148, HCMV infection, congenital HCMV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision to withdraw before study started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (estimated)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: CSJ148CSJ148 |
| Placebo | Placebo comparator | Other: Placebo5% dextrose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSJ148Active | Biological | Active |
| PlaceboNo Drug | Other | Placebo |
Primary outcome
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
7 secondary outcomes
Change from Baseline in the Reduction in symptomatic congenital human cytomegalovirus (HCMV) disease (compared to placebo)
Time frame: Day 218
Change from baseline in congenital human cytomegalovirus (HCMV) urine viral load in neonates at birth
Time frame: Baseline, Day 218
Pharmacokinetic concentration data of CSJ148
Time frame: Days 1,29,57,85,218,141,169, 197, 218
CSJ148 concentration in cord blood
Time frame: Day 218
Immunogenicity of CSJ148 in pregnant women
Time frame: Days 1,29,57,85,218,141,169, 197, 218
Immunogenicity of CSJ148 in cord blood
Time frame: Day 218
CSJ148 concentration in amniotic fluid
Time frame: Day 218
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSJ148 in people with HCMV Infection, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event rate of fetuses or neonates with congenital human cytomegalovirus (HCMV) infection (time frame: Day 218). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.