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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01220115
First received: October 11, 2010
Last updated: January 30, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Data collection [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations


Estimated Enrollment: 155
Study Start Date: January 2010
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220115

Contacts
Contact: Novartis Pharmaceuticals +1 800 340 6843

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01220115     History of Changes
Other Study ID Numbers: CICL670AUS38
Study First Received: October 11, 2010
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014