Sickle Cell DiseasePRIMNCT07554547
Crizanlizumab Pregnancy Outcomes Intensive Monitoring
An observational study of Sickle Cell Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP). Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2020to 30 Jun 2025
- Phase
- Observational
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database
Who may be able to join
- All prospective and retrospective pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database were eligible for the PRIM program.
Who cannot join
- Cases with the following exclusion criteria were excluded from the crizanlizumab PRIM study:
- Patients who upon initial case report refuse to be contacted to obtain any FU information. In such cases necessary information using PRIM follow-up checklists cannot be obtained.
- Indirect cases (reported by someone other than the patient or the healthcare provider (HCP)) for which the reporter refuses to provide FU information and the patient or HCP cannot be identified based on the information provided.
- Pregnancies of female partners of male patients taking crizanlizumab. Such cases were to be processed as per Manual for Argus Processing (MAP).
- Cases lacking reporter contact details (e.g., cases from social media) or incomplete cases in which data was missing to allow classification of pregnancy or infant outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).
- Conditions
- Sickle Cell Disease
- Keywords
- Crizanlizumab,, Adakveo®,, Sickle cell disease,, Pregnancy Outcomes
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnancies resulting in fetal loss
proportion of pregnancies resulting in fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), among pregnant women exposed to crizanlizumab within 105 days prior to LMP or at any time during pregnancy.
Measured: Duration of study, up to 56 months
Secondary outcomes (2)
Proportion of major congenital malformations among pregnancies exposed to crizanlizumab
proportion of major congenital malformations among pregnancies exposed to crizanlizumab up to 105 days before LMP and during pregnancy reported to Novartis amongst (i) live births and (ii) live births plus still births plus termination of pregnancy for fetal anomaly (TOPFA).
Measured: Duration of study, up to 56 months
Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab
proportion of overall congenital malformations among pregnancies exposed to crizanlizumab up to 105 days before LMP and during pregnancy reported to Novartis with the outcome of total live births, and live birth plus still births and TOPFA.
Measured: Duration of study, up to 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 Nov 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554547
- Sponsor's protocol ID
- CSEG101A2404
- Other IDs
- EUPAS39412
- Acronym
- PRIM
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)
- ClinicalTrials.gov ID
- NCT07554547
- Acronym / sponsor ID
- PRIM / CSEG101A2404
- Conditions
- Sickle Cell Disease
- Keywords
- Crizanlizumab,, Adakveo®,, Sickle cell disease,, Pregnancy Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 28 Apr 2026 (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.
This was a non-interventional study to evaluate pre-specified pregnancy and infant outcomes in women treated with crizanlizumab during pregnancy or within 105 days before the last menstrual period (LMP).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database
Key inclusion criteria (1 listed)
- All prospective and retrospective pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database were eligible for the PRIM program.
Key exclusion criteria (5 listed)
- Cases with the following exclusion criteria were excluded from the crizanlizumab PRIM study:
- Patients who upon initial case report refuse to be contacted to obtain any FU information. In such cases necessary information using PRIM follow-up checklists cannot be obtained.
- Indirect cases (reported by someone other than the patient or the healthcare provider (HCP)) for which the reporter refuses to provide FU information and the patient or HCP cannot be identified based on the information provided.
- Pregnancies of female partners of male patients taking crizanlizumab. Such cases were to be processed as per Manual for Argus Processing (MAP).
- Cases lacking reporter contact details (e.g., cases from social media) or incomplete cases in which data was missing to allow classification of pregnancy or infant outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of pregnancies resulting in fetal loss
Time frame: Duration of study, up to 56 months
proportion of pregnancies resulting in fetal loss (intrauterine death resulting in stillbirth, spontaneous abortion, or induced termination), among pregnant women exposed to crizanlizumab within 105 days prior to LMP or at any time during pregnancy.
2 secondary outcomes
Proportion of major congenital malformations among pregnancies exposed to crizanlizumab
Time frame: Duration of study, up to 56 months
Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab
Time frame: Duration of study, up to 56 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Sickle Cell Disease, Cognitive Impairment
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of pregnancies resulting in fetal loss (time frame: Duration of study, up to 56 months). 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 25 Sep 2026.