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

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.
 
ClinicalTrials.gov Identifier: NCT01220115
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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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.

Condition or disease
Sickle Cell Disease

Study Design
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Study Type : Observational
Actual Enrollment : 498 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients
Study Start Date : January 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


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

Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01220115    
Other Study ID Numbers: CICL670AUS38
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: May 2015
Keywords provided by Novartis:
sickle cell disease
iron over load
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn