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A 5-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients (FISCO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220115
First Posted: October 13, 2010
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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.

Condition
Sickle Cell Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 5-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Document current treatment patterns, natural history and outcomes in patients with sickle cell disease [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • Data collection [ Time Frame: up to 5 years ]
    Collection of the following data:Current therapies used for the treatment of SCD Current transfusion practices, Difference in treatments between pediatric and adult patients, Use of chelation therapies, Frequency and types of crises including Frequency of hospitalizations, Incidence of end organ damage (caridac, renal, pulmonary,liver), Quality of life assessed by PedsQL TM Pediatric Quality of Life Inventory for patients 2- <18 years old and SF-36® Health Survey for patients 18 years old and older

  • Measure Sickle cell crisis and hospitalizations [ Time Frame: up to 5 years ]
    To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations


Enrollment: 498
Study Start Date: January 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
Patients aged 2 to less than 12
No treatment patients aged 12 to less than 18
Patients aged 12 to less than 18
No treatment Patients greater than 18 years
patients greater than 18 years

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Sickle cell disease age 2 years and older
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220115


  Show 42 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01220115     History of Changes
Other Study ID Numbers: CICL670AUS38
First Submitted: October 11, 2010
First Posted: October 13, 2010
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Novartis:
sickle cell disease
iron over load

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn