D5136C00008 HESTIA2, Phase IIB, Sickle Cell Disease (Ticagrelor)
Research type
Research Study
Full title
A randomised, double-blind, double-dummy, parallel-group, multicenter, phase IIb study to evaluate the effect of ticagrelor 10 mg and 45 mg bid versus placebo in reducing the number of days with pain in young adults with sickle cell disease.
IRAS ID
180799
Contact name
Banu Kaya
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-005420-10
Duration of Study in the UK
years, 8 months, 16 days
Research summary
The study will assess the effect of two different doses (10mg and 45mg twice daily) of ticagrelor (the study drug) versus placebo in reducing the number of days with pain in both male and female sickle cell disease (SCD) patients aged between 18 and 30 years old.
Ticagrelor is a platelet aggregation inhibitor which decreases platelet aggregation, part of the sequence of events leading to the formation of a thrombus or 'clot'. The study will assess whether ticagrelor can help reduce the pain associated with vaso-occlusive crisis (VOC, the main complication of SCD) and the need for painkillers (analgesics).
The study will start with a 4 week single-blind (participants will not be told which treatment they are receiving) double-dummy (a technique for retaining the blinding of the study, where the two treatments cannot be made identical) placebo run-in period. Eligible participants will then be randomised in a 1:1:1 ratio (30 to each treatment group) to receive double-blind (neither the participant nor study doctor knows which treatment is being given) double-dummy ticagrelor 10 mg twice daily, 45 mg twice daily, or placebo twice daily for 12 weeks. Participants will be followed for 2 weeks safety assessment after 12 week study treatment period. The expected study duration for an individual participant is approximately 18 weeks.
This study will be conducted at approximately 32 centres in approximately 8 countries. It is expected that approximately 90 patients of both sexes will be randomised to study treatment.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0270
Date of REC Opinion
22 Sep 2015
REC opinion
Further Information Favourable Opinion