Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

May 2, 2019

Primary Completion Date

April 17, 2024

Study Completion Date

February 26, 2025

Conditions
Immune Thrombocytopenia
Interventions
DRUG

Eltrombopag

"Starting dose for eltrombopag will be based on manufacturer recommendations, and drug will be titrated to effect per guidelines.~* Children 1 to 5 years: Initial: 25 mg once daily~* Children ≥6 years and Adolescents: Initial: 50 mg once daily (25 mg once daily for patients of East-Asian ethnicity \[e.g., Chinese, Japanese, Korean, Taiwanese\])~Dose should be titrated based on platelet response. Maximum dose: 75 mg once daily."

DRUG

Steroids

Prednisone/Prednisolone 4mg/kg/day (Max 120 mg/day) x 4 day

DRUG

IVIG

IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy)

DRUG

Rho(D) Immune Globulin

Anti-D globulin 75 mcg/kg x1 (no steroids for pre-medication or adjunctive therapy)

Trial Locations (27)

10032

Columbia University Irving Medical Center, New York

10065

Weill Cornell Medical College, New York

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

27710

Duke University Medical Center, Durham

28203

Levine Cancer Institute, Charlotte

30342

Alfac Cancer and Blood Disorder Center: Scottish Rite, Atlanta

32610

University of Florida College of Medicine, Gainesville

35233

Children's of Alabama, Birmingham

38105

St. Jude Children's Hospital, Memphis

43205

Nationwide Children's Hospital, Columbus

46202

Riley Hospital for Children-Indiana University, Indianapolis

53792

University of Wisconsin, Madison

55404

Children's Hospital and Clinics of Minnesota, Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

68198

University of Nebraska Medical Center, Omaha

72202

Arkansas Children's Hospital, Little Rock

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

85016

Phoenix CHildren's Hospital, Phoenix

92868

Children's Hospital of Orange County, Orange

94158

UCSF Benioff Children's Hospital, San Francisco

97227

Randall Children's Hospital, Portland

97239

Oregon Health and Science University, Portland

02115

Boston Children's Hospital, Boston

07601

Hackensack University Medical Center, Hackensack

02903

Hasbro Children's Hospital, Providence

All Listed Sponsors
collaborator

Boston Children's Hospital

OTHER

collaborator

University of California, San Francisco

OTHER

lead

Baylor College of Medicine

OTHER

NCT03939637 - Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children | Biotech Hunter | Biotech Hunter