Sickle Cell Disease: A Retrospective Chart Review

Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review

Sponsors

Lead Sponsor: Novartis Pharmaceuticals

Source Novartis
Brief Summary

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.

Overall Status Completed
Start Date July 2011
Completion Date July 2012
Primary Completion Date July 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Sickle cell complications average of 5 years
Secondary Outcome
Measure Time Frame
Utilization of health care delivery to treat sickle cell complications average of 5 years
Overall survival average of 5 years
Utilization of blood transfusions (patients with frequent transfusions only) average of 5 years
Burden of iron overload (patients with frequent transfusions only) average of 5 years
Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only) average of 5 years
Enrollment 261
Condition
Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Location
Facility:
Tulane University | New Orleans, Louisiana, 70112, United States
Universit of Tennessee | Memphis, Tennessee, 38163, United States
Location Countries

United States

Verification Date

October 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Sickle cell patients non-transfused

Label: Sickle cell patients transfused with no ICT

Label: Sickle cell patients transfused with ICT

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov