Sickle Cell Disease: A Retrospective Chart Review

Completed

• Conditions: Sickle Cell Anemia

• Registration Number: NCT01441375
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-27
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sickle cell complications	average of 5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Universit of Tennessee; 🇺🇸 Memphis, Tennessee, United States