Eltrombopag for Enhancing Platelet Engraftment in Pediatric Patients Undergoing Cord Blood Transplantation

PHASE2UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Pediatric Patients Undergoing Allogeneic Cord Blood Transplantation.
Interventions
DRUG

eltrombopag

"Children ≥= 40 kg BW:~From day +1, start eltrombopag 100 mg/d. If primary end point not reached on day +14, then from day +15 - 150 mg/d. If primary end point not reached on day +28 then from day +29 - 200 mg/d (maximal dose).~Children 20-40 kg BW:~From day +1, start eltrombopag 50 mg/d. If primary end point not reached on day +14, then from day +15 - 75 mg/d. If primary end point not reached on day +28 then from day +29 - 100 mg/d.If primary end point not reached on day +42, then from day +43 and on - 150 mg/d (maximal dose).~Children \< 20 kg BW:~From day +1, start eltrombopag - 2 mg/kg/d. If primary end point not reached on day +14, then from day +15 - 3 mg/kg/d. If primary end point not reached on day +28 then from day +29 - 3.5 mg/kg (maximal dose).~If present dose not tolerated, return to last tolerated dose. Eltrombopag will be discontinued after platelet count has exceeded 50,000/microliter for 14 consecutive days without administration of platelets."

Trial Locations (2)

49202

RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

Unknown

RECRUITING

Hadassah hospital, Jerusalem

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

moshe yeshurun

OTHER