NCT07554547Completed
Crizanlizumab Pregnancy Outcomes Intensive Monitoring
Adakveo® (Crizanlizumab) PRegnancy Outcomes Intensive Monitoring (PRIM)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 13 (actual)
- First submitted
- 21 Apr 2026
- Start date
- 15 Nov 2020
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Sickle cell disease
- NCT number
- NCT07554547
What you commit to
- Study type: Observational
- Participants enrolled: 13
- From 15 Nov 2020 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.