Crizanlizumab Pregnancy Outcomes Intensive Monitoring

NCT07554547 | Completed

• 2 other identifiers: CSEG101A2404EUPAS39412
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of study, up to 56 months

Secondary Outcomes (2)

• Proportion of major congenital malformations among pregnancies exposed to crizanlizumab

  Duration of study, up to 56 months

• Proportion of overall congenital malformations among pregnancies exposed to crizanlizumab

  Duration of study, up to 56 months

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnancy cases exposed to crizanlizumab during pregnancy or 105 days before LMP reported to the Novartis global safety database

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative SIte

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: November 15, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)