Thrombocytopenia, Neonatal AlloimmunePhase 3FREESIA-1NCT06449651
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
A Phase 3 study testing Nipocalimab in people with Thrombocytopenia, Neonatal Alloimmune, run by Janssen Research & Development, LLC at 21 sites in 12 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Thrombocytopenia, Neonatal Alloimmune
- What is being tested?
- Nipocalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 21 sitesin 12 countries
- Study dates
- 11 Nov 2024to 5 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
- Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
- Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
- Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
- For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
Who cannot join
- Currently pregnant with multiple gestations (twins or more)
- History of severe preeclampsia in a previous pregnancy
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
- Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Trial locations and contacts
21 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 12 countries
Norway4 sites, 4 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5009
- Recruiting
Oslo University Hospital HF Ulleval sykehus
Oslo, 0455
- Recruiting
Universitetssykehuset Nord-Norge HF
Tromsø, 9019
- Recruiting
St. Olavs Hospital
Trondheim, 7030
Brazil3 sites
- Completed
Instituto de Medicina Integral Professor Fernando Figueira
Recife, 50070-902
- Completed
IDOR - Regional Rio de Janeiro
Rio de Janeiro, 22281 100
- Completed
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 000
Slovakia3 sites
- Completed
Univerzitna nemocnica L. Pasteura Kosice
Košice, 04190
- Completed
Univerzitná nemocnica Martin
Martin, 036 01
- Completed
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
France2 sites
- Completed
CHRU Lille
Lille, 59000
- Completed
Hopital trousseau- APHP
Paris, 75012
Italy2 sites
- Completed
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, 20122
- Completed
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, 00168
Slovenia1 site
- Completed
Univerzitetni klinicni center Ljubljana
Ljubljana, 1000
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset Huddinge
Stockholm, SE-141 86
Switzerland1 site
- Completed
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, 1011
About this study
Official title: Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Conditions
- Thrombocytopenia, Neonatal Alloimmune
- Being tested
- Nipocalimab, Placebo
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NipocalimabDrug
Also called JNJ-80202135, JNJ-86507083
Nipocalimab will be administered intravenously.
PlaceboDrug
Placebo will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Nipocalimab | Active comparator | Maternal participants will receive nipocalimab Intravenously (IV). Receives: Drug: Nipocalimab |
| Placebo | Placebo comparator | Maternal participants will receive placebo IV. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count <30*10^9/L will be reported.
Measured: Up to 1 week post birth
Secondary outcomes (24)
Neonate/Fetus With Adjudicated Bleeding
Neonate/fetus With adjudicated bleeding will be reported.
Measured: Up to 1 Week post birth
Platelet Count at Birth in a Neonate
Platelet count at birth in a neonate will be reported.
Measured: At birth
Neonate/Fetus with Outcome of Death
Fetus/neonate with outcome of death will be reported.
Measured: Up to 1 Week post birth
Platelet Count at Birth <10×10^9/L in a Neonate
Platelet count at birth <10×10^9/L in a neonate will be reported.
Measured: At birth
Platelet Count at Birth <30×10^9/ L In a Neonate
Platelet count at birth <30×10^9/L in a neonate will be reported.
Measured: At birth
Platelet Count at Birth <50×10^9/L In a Neonate
Platelet count at birth <50×10^9/L in a neonate will be reported.
Measured: At birth
Platelet Count at Birth <150×10^9/L In a Neonate
Platelet count at birth <150×10^9/L in a neonate will be reported.
Measured: At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth
Nadir platelet count in a neonate will be reported.
Measured: Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)
Neonate(s) who require at least one platelet transfusion(s) will be reported.
Measured: Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus
Number of Platelet transfusion(s) per neonate will be reported.
Measured: Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus
Number of donor exposures for neonates who received platelet transfusion(s) will be reported.
Measured: Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding
Neonate/Fetus With adjudicated severe bleeding will be reported.
Measured: Up to 1 week post birth
Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia
Neonates with IVIG for the treatment of thrombocytopenia will be reported.
Measured: Up to 1 Week post birth
Maternal Participants With Treatment-Emergent Adverse Event (TEAE)
Maternal participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: From randomization up to 24 weeks postpartum
Maternal Participants With Serious Adverse Event (SAE)
Maternal participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important.
Measured: From randomization up to 24 weeks postpartum
Maternal Participants With Adverse Event of Special Interest (AESI)
Maternal participants with an AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and/or pulmonary embolism, and clinically significant bleeding.
Measured: From randomization up to 24 weeks postpartum
Maternal Participants with TEAE Leading to Discontinuation of Study Intervention
Maternal participants with TEAE leading to discontinuation of study intervention will be reported.
Measured: Up to Week 104
Neonate/Infant with TEAE
Neonatal/infant participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to Week 104
Neonate/Infant with SAE
Neonatal/infant participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically Important.
Measured: Up to Week 104
Neonate/Infant with AESI
Neonatal/infant participants with AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as: In infants- clinically significant mortalities in fetus/neonates due to maternal infections, and hypogammaglobulinemia.
Measured: Up to Week 104
Fetus/Neonate With TEAE of Bleeding
Fetus/Neonate with TEAE of Bleeding will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to Week 104
Neonate With TEAE of Infection
Neonate with TEAE of Infection will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to Week 104
Infant Development as Measured by Bayley Scales at Week 52 and Week 104
The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, motor skills scales are directly administered to the infant, while social-emotional, and adaptive behavior scales are caregiver questionnaires. The scores are standardized using norm reference samples with representative demographics and age adjusted for prematurity.
Measured: At Week 52 and 104
Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum
Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start11 Nov 2024
- Primary completion5 Dec 2029 (estimated)
- Study completion5 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thrombocytopenia, Neonatal AlloimmuneStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449651
- Sponsor's protocol ID
- 80202135FNAIT3001
- Other IDs
- 80202135FNAIT3001, 2023-504307-88-00, 2023
- Acronym
- FREESIA-1
- Status last verified
- Nov 2026
- First submitted
- 4 Jun 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Baker P, Keshinro B, Stegmann B, Oey A, Shu C, Heerwegh D, Zaha R, Van Valkenburgh H. Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(9):1256-1263. doi: 10.1055/a-2761-1775. Epub 2025 Dec 29.
PubMed 41461173Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28.
PubMed 40720970
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
- ClinicalTrials.gov ID
- NCT06449651
- Acronym / sponsor ID
- FREESIA-1 / 80202135FNAIT3001
- Conditions
- Thrombocytopenia, Neonatal Alloimmune
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 5 Dec 2029 (estimated)
- Study completion
- 5 Dec 2029 (estimated)
- First posted
- 10 Jun 2024 (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 this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nipocalimab | Active comparator | Drug: NipocalimabMaternal participants will receive nipocalimab Intravenously (IV). |
| Placebo | Placebo comparator | Drug: PlaceboMaternal participants will receive placebo IV. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
- Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
- Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
- Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
- For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
Key exclusion criteria (5 listed)
- Currently pregnant with multiple gestations (twins or more)
- History of severe preeclampsia in a previous pregnancy
- History of myocardial infarction, unstable ischemic heart disease, or stroke
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
- Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
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 |
|---|---|---|
| NipocalimabAlso: JNJ-80202135, JNJ-86507083Nipocalimab will be administered intravenously. | Drug | Nipocalimab |
| PlaceboPlacebo will be administered intravenously. | Drug | Placebo |
Primary outcome
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
Time frame: Up to 1 week post birth
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count <30*10^9/L will be reported.
24 secondary outcomes
Neonate/Fetus With Adjudicated Bleeding
Time frame: Up to 1 Week post birth
Platelet Count at Birth in a Neonate
Time frame: At birth
Neonate/Fetus with Outcome of Death
Time frame: Up to 1 Week post birth
Platelet Count at Birth <10×10^9/L in a Neonate
Time frame: At birth
Platelet Count at Birth <30×10^9/ L In a Neonate
Time frame: At birth
Platelet Count at Birth <50×10^9/L In a Neonate
Time frame: At birth
Platelet Count at Birth <150×10^9/L In a Neonate
Time frame: At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth
Time frame: Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)
Time frame: Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus
Time frame: Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus
Time frame: Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding
Time frame: Up to 1 week post birth
Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia
Time frame: Up to 1 Week post birth
Maternal Participants With Treatment-Emergent Adverse Event (TEAE)
Time frame: From randomization up to 24 weeks postpartum
Maternal Participants With Serious Adverse Event (SAE)
Time frame: From randomization up to 24 weeks postpartum
Maternal Participants With Adverse Event of Special Interest (AESI)
Time frame: From randomization up to 24 weeks postpartum
Maternal Participants with TEAE Leading to Discontinuation of Study Intervention
Time frame: Up to Week 104
Neonate/Infant with TEAE
Time frame: Up to Week 104
Neonate/Infant with SAE
Time frame: Up to Week 104
Neonate/Infant with AESI
Time frame: Up to Week 104
Fetus/Neonate With TEAE of Bleeding
Time frame: Up to Week 104
Neonate With TEAE of Infection
Time frame: Up to Week 104
Infant Development as Measured by Bayley Scales at Week 52 and Week 104
Time frame: At Week 52 and 104
Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 41461173Baker P, Keshinro B, Stegmann B, Oey A, Shu C, Heerwegh D, Zaha R, Van Valkenburgh H. Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Jul;43(9):1256-1263. doi: 10.1055/a-2761-1775. Epub 2025 Dec 29.
- Derived from this study: PubMed 40720970Tiller H, Tiblad E, Baker P, Van Valkenburgh H, Heerwegh D, Keshinro B. Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Am J Perinatol. 2026 Apr;43(5):648-656. doi: 10.1055/a-2666-5642. Epub 2025 Jul 28.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
21 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nipocalimab in people with Thrombocytopenia, Neonatal Alloimmune, run by Janssen Research & Development, LLC at 21 sites in 12 countries.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Norway, Brazil, Slovakia, France, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L (time frame: Up to 1 week post birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449651, which also lists 2 linked publications.
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 3 Nov 2026.