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A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients (FISCO)

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Novartis

Status

Completed

Conditions

Sickle Cell Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT01220115
CICL670AUS38

Details and patient eligibility

About

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.

Enrollment

498 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

498 participants in 3 patient groups

No treatment
Description:
Patients aged 2 to less than 12
No treatment patients aged 12 to less than 18
Description:
Patients aged 12 to less than 18
No treatment Patients greater than 18 years
Description:
patients greater than 18 years

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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