A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients

Novartis42 sites in 1 country498 target enrollmentJanuary 2010

ConditionsSickle Cell Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sickle Cell Disease
Sponsor: Novartis
Enrollment: 498
Locations: 42
Primary Endpoint: Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

September 2014

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients with HbSS, HbS/beta-thalassemia and HbSC
•Age \> 2 years old.
•Written informed consent by the patient or legal guardians, and pediatric assent where indicated.

Exclusion Criteria

•Patients with Sickle Cell trait (HbAS) are not eligible for the study
•Patient or legal guardians unable or unwilling to give consent, or pediatric assent where indicated.