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

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT01220115
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-05
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Measure Sickle cell crisis and hospitalizations	up to 5 years	To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations
Data collection	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

Trial Locations

Locations (42)

Hematology Oncology Services of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Children's Hospital Oakland (CHO); 🇺🇸 Oakland, California, United States

Children's Hospital of Orange County Sickle Cell Disease Center; 🇺🇸 Orange, California, United States

Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center; 🇺🇸 San Diego, California, United States

Hematology Oncology, P.C.; 🇺🇸 Stamford, Connecticut, United States

Howard University; 🇺🇸 Washington, District of Columbia, United States

Broward Oncology Associates, P.A.; 🇺🇸 Fort Lauderdale, Florida, United States

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States

Innovative Medical Research; 🇺🇸 Miami, Florida, United States

M.D. Anderson Cancer Center Orlando; 🇺🇸 Orlando, Florida, United States

Scroll for more (32 remaining)