Hydroxyurea and Transfusion

• Status: Completed
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's National Research Institute; Children's Research Institute
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

1. Diagnosis of SCA (Hb SS or Sβ0 thalassemia).

2. On simple chronic transfusion therapy for stroke prevention (primary or secondary prevention) for ≥1 year with no plans to stop simple chronic transfusion in the next year.

Exclusion Criteria:

1. Poor adherence to simple transfusion regimen as defined by having an HbS >45% at any time in the last year AND a transfusion interval >5 weeks.

2. Treatment with hydroxyurea in the 12 months prior to study enrollment.

3. Abnormal initial laboratory values (temporary exclusions):

1. Absolute neutrophil count <1.5 x 10^9/L

2. Platelet count <100 x 10^9/L

3. Serum creatinine more than twice upper limit for age

4. Pregnancy or unwillingness to use a medically acceptable form of contraception if sexually active.