NCT03720626

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to SEG101, Crizanlizumab

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

First QC Date

October 24, 2018

Last Update Submit

April 9, 2026

Conditions

Keywords

MAPManaged Access ProgramSEG101Crizanlizumab

Interventions

Patients receive crizanlizumab

Also known as: SEG101

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
  • The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
  • There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
  • The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
  • Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
  • Managed Access provision is allowed per local laws/regulations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • DeBonnett L, Joshi V, Silva-Pinto AC, Colombatti R, Pasanisi A, Arcioni F, Cancado RD, Sarp S, Sarkar R, Soliman W. Real-World Evidence of Crizanlizumab Showing Reductions in Vaso-Occlusive Crises and Opioid Usage in Sickle Cell Disease. Eur J Haematol. 2025 Feb;114(2):293-302. doi: 10.1111/ejh.14323. Epub 2024 Oct 29.

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

crizanlizumab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

MAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 25, 2018

Last Updated

April 14, 2026

Record last verified: 2026-04