Trial intelligence / Profile preview

Hydroxyurea and Transfusion for Sickle Cell Anemia

NCT03644953Phase 2

Key facts

Status: Completed
Start: Oct 2018
Primary completion: Jul 2021
Countries: 1
Sponsor: Children's National Research Institute
Modality: Small Molecules

Drugs: hydroxyurea
Conditions: sickle cell anemia (SCA)

Overview

Phase 2, open-label, single-arm trial of hydroxyurea in sickle cell anemia (SCA), sponsored by Children's National Research Institute. Primary endpoints: Recruitment ratio at 1 year, Retention ratio at 1 year and 1 more. Started Oct 2018; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Hydroxyurea and Transfusion (HAT)
Combination hydroxyurea and simple chronic transfusion therapy

Who it enrols

Patients with Hb SS or Sβ0 thalassemia on simple chronic transfusion for stroke prevention for at least one year, excluding those with poor adherence or recent hydroxyurea use.

Endpoints

Primary

Recruitment ratio1 year
Retention ratio1 year
Hydroxyurea adherence ratio1 year

Secondary

Proportion of subjects who develop an HbS >45% AND an Hb >11.0 g/dL1 year
Volume of red blood cells transfused per patient weight1 year

Beyond the preview

Go deeper on NCT03644953.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03644953.