Sickle Cell Disease: A Retrospective Chart Review

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01441375
First received: September 7, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

This study is a retrospective chart review of sickle cell patients and will include patients whom have received blood transfusions and those whom have not. Of the transfused patients, it will also include those whom have received chelation therapy and those whom have not.


Condition
Sickle Cell Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sickle cell complications [ Time Frame: average of 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Utilization of health care delivery to treat sickle cell complications [ Time Frame: average of 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: average of 5 years ] [ Designated as safety issue: Yes ]
  • Utilization of blood transfusions (patients with frequent transfusions only) [ Time Frame: average of 5 years ] [ Designated as safety issue: No ]
  • Burden of iron overload (patients with frequent transfusions only) [ Time Frame: average of 5 years ] [ Designated as safety issue: Yes ]
  • Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only) [ Time Frame: average of 5 years ] [ Designated as safety issue: No ]

Enrollment: 261
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sickle cell patients non-transfused
Sickle cell patients transfused with no ICT
Sickle cell patients transfused with ICT

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Sickle cell anemia

Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of Sickle Cell Disease (SCD) and a confirmed genotype
  2. Patients ≥ 16 years of age
  3. Patients with ≥ 6 months of follow-up data available from first SCD treatment at the center after they reach 16 years old
  4. At least one SF reading during a non-acute phase on or after the first SCD treatment at the center after they reach 16 years old

Exclusion Criteria:

  1. Patients who participated in a clinical trial for an iron chelating medication or in a clinical trial for transfusions for SCD (1) within the six months before the index date or (2) during the patient observation period
  2. Patients with sickle cell trait

Other protocol-defined inclusion/exclusion criteria may apply

  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: NCT01441375

Locations
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Tennessee
Universit of Tennessee
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01441375     History of Changes
Other Study ID Numbers: CICL670A2418
Study First Received: September 7, 2011
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Sickle cell anemia

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

ClinicalTrials.gov processed this record on August 28, 2014