Table 1. Active pediatric phase 2 and 3... | American Society of Hematology

Table 1.

Active pediatric phase 2 and 3 trials for thrombotic disorders

ClinicalTrials.gov identifier	Name	Study design	Condition	n (age)	Intervention	Primary outcome(s)	Study start date
Treatment
NCT00687882	Kids-DOTT	Phase 3, RCT	Duration of therapy in pediatric VTE	608 (birth to <21 y)	Shortened (6 wk) duration of AC	Symptomatic recurrent VTE Major plus CRNM bleeding	March 2008
NCT02464969	—	Phase 3, RCT	VTE	250 (0 to <18 y)	Apixaban	Composite of major and CRNM bleeding Composite of symptomatic and asymptomatic VTE and VTE-related mortality	November 2015
NCT02981472	SAXOPHONE	Phase 2	Congenital or acquired heart disease	200 (28 d to <18 y)	Apixaban	Incidence of bleeding events	January 2017
NCT02798471	Hokusai Study	Phase 3, RCT	VTE	274 (0 to <18 y)	Edoxaban	Composite of symptomatic recurrence, VTE-related death, and thrombotic burden	March 2017
Prevention
NCT02369653	PREVAPIX-ALL	Phase 3, RCT	Malignancy	500 (<18 y)	Apixaban	Composite of VTE and VTE-related deaths Major bleeding	April 2015
NCT02846532	UNI..VERSE	Phase 3, RCT	Single ventricle physiology	112 (2-8 y)	Rivaroxaban	Major bleeding Venous and arterial thromboses	November 2016
NCT04354155	COVAC-TP	Phase 2	SARS-CoV-2 infection	38 (birth to <18 y)	Twice-daily low dose enoxaparin thromboprophylaxis	Safety of in-hospital thromboprophylaxis	June 2020

ClinicalTrials.gov identifier	Name	Study design	Condition	n (age)	Intervention	Primary outcome(s)	Study start date
Treatment
NCT00687882	Kids-DOTT	Phase 3, RCT	Duration of therapy in pediatric VTE	608 (birth to <21 y)	Shortened (6 wk) duration of AC	Symptomatic recurrent VTE Major plus CRNM bleeding	March 2008
NCT02464969	—	Phase 3, RCT	VTE	250 (0 to <18 y)	Apixaban	Composite of major and CRNM bleeding Composite of symptomatic and asymptomatic VTE and VTE-related mortality	November 2015
NCT02981472	SAXOPHONE	Phase 2	Congenital or acquired heart disease	200 (28 d to <18 y)	Apixaban	Incidence of bleeding events	January 2017
NCT02798471	Hokusai Study	Phase 3, RCT	VTE	274 (0 to <18 y)	Edoxaban	Composite of symptomatic recurrence, VTE-related death, and thrombotic burden	March 2017
Prevention
NCT02369653	PREVAPIX-ALL	Phase 3, RCT	Malignancy	500 (<18 y)	Apixaban	Composite of VTE and VTE-related deaths Major bleeding	April 2015
NCT02846532	UNI..VERSE	Phase 3, RCT	Single ventricle physiology	112 (2-8 y)	Rivaroxaban	Major bleeding Venous and arterial thromboses	November 2016
NCT04354155	COVAC-TP	Phase 2	SARS-CoV-2 infection	38 (birth to <18 y)	Twice-daily low dose enoxaparin thromboprophylaxis	Safety of in-hospital thromboprophylaxis	June 2020

CRNM, clinically relevant, nonmajor bleeding.