A Study to Assess the Efficacy and Safety of Eltrombopag as a Rescue of Isolated Chemotherapy-induced Thrombocytopenia

PHASE3UnknownINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

March 31, 2019

Study Completion Date

August 31, 2019

Conditions
Solid Tumor
Interventions
DRUG

Eltrombopag

This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.

DRUG

Placebo

This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.

Trial Locations (3)

Unknown

Department of Obstetrics & Gynecology and Department of Oncology Chang Gung Memorial Hospital, Chiayi City

Department of Obstetrics & Gynecology Chang Gung Memorial Hospital, Kaohsiung City

Division of Gynecologic Oncology, Department of Obstetrics & Gynecology and Division of Oncology Chang Gung Memorial Hospital, Linkou District

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Chang Gung Memorial Hospital

OTHER