Crizanlizumab Pregnancy Outcomes Intensive Monitoring

Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07554547

Acronym

PRIM

Enrollment

Registered

2026-04-28

Start date

2020-11-15

Completion date

2025-06-30

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Crizanlizumab,, Adakveo®,, Sickle cell disease,, Pregnancy Outcomes

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 100 Years

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

Cases with the following

Design outcomes

Primary

Measure	Time frame	Description
Proportion of pregnancies resulting in fetal loss	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.

Secondary

Measure	Time frame	Description
Proportion of major congenital malformations among pregnancies exposed to crizanlizumab	Duration of study, up to 56 months	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).
Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab	Duration of study, up to 56 months	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.

Countries

Switzerland

Contacts

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results