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Hydroxyurea and Transfusion — HAT  

Sickle Cell Disease Clinical Trial

Official title:
Hydroxyurea and Transfusion: Pilot Study of Combination Therapy for Patients With Sickle Cell Anemia

Clinical Trial Summary

This study will prospectively investigate the feasibility, safety, and transfusion requirements of adding hydroxyurea to simple chronic transfusions for patients with sickle cell anemia already on chronic transfusions.

Clinical Trial Description

This is a single-arm, prospective study of hydroxyurea added to simple chronic transfusions, combination treatment termed hydroxyurea and transfusion (HAT). The primary objective of the study is to determine the feasibility of HAT for patients with sickle cell anemia (SCA) currently being treated only with simple transfusions for stroke prevention. Secondary objectives include: to evaluate the safety of HAT and to determine if HAT decreases transfusion requirements in this patient population. Exploratory objectives include: to evaluate with HAT changes in pre-transfusion laboratories and biomarkers of cerebrovascular disease progression, and to describe changes on brain imaging. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03644953
Study type Interventional
Source Children's National Research Institute
Contact
Status Completed
Phase Phase 2
Start date October 30, 2018
Completion date July 1, 2021
View Details
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