A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

Phase 3 Terminated 341 enrolled Eli Lilly and Company Daiichi Sankyo · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.

Timeline

Start: 2013-04
Primary completion: 2015-07
Completion: 2015-12

Outcome

Missed primary endpoint

Stopped: “The study is being terminated for lack of efficacy.”

registry analysis (unspecified test); Prasugrel vs Placebo; p = .117; Rate Ratio 0.83 (95% CI 0.66 to 1.05); Andersen-Gill model NCT01794000 ↗

paper rate of vaso-occlusive crisis was not significantly lower among those who received prasugrel than among those who received placebo. PMID 26644172 ↗

Publications

Heeney MM, Hoppe CC, Abboud MR, Inusa B, Kanter J, Ogutu B, Brown PB, Heath LE, Jakubowski JA, Zhou C, Zamoryakhin D, Agbenyega T, Colombatti R, Hassab HM, Nduba VN, Oyieko JN, Robitaille N, Segbefia CI, Rees DC; DOVE Investigators. A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events. N Engl J Med. 2016 Feb 18;374(7):625-35. doi: 10.1056/NEJMoa1512021. Epub 2015 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prasugrel	Small molecule	0.12 mg/kg	Oral