SLCTR/2018/024.

Trial name or title	Efficacy and safety of oral hydroxyurea in transfusion‐dependent beta‐thalassaemia: a randomised double‐blind placebo‐controlled clinical trial
Methods	RCT
Participants	Beta‐thalassaemia major or HbE beta‐thalassaemia patients who required more than 10 transfusions during the preceding year
Interventions	Hydroxyurea
Outcomes	Complete response to treatment is defined as complete cessation of blood transfusions with a baseline haemoglobin > 9.0g/dL during the treatment period Partial response is defined as over 50% reduction in transfusion requirement during treatment period (≦ 3 transfusions during treatment 6 months) with baseline haemoglobin > 7.0g/dL
Starting date	01 September 2018
Contact information	sachith.mettananda@kln.ac.lk
Notes

RCT: randomised controlled trial