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Completed

NCT Number: NCT07554547

Crizanlizumab Pregnancy Outcomes Intensive Monitoring

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).

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative SIte

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of major congenital malformations among pregnancies exposed to crizanlizumab

    Time frame: 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).

  2. Proportion of overall 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 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PRIM

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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