NCT03025698 - A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2017

Primary Completion Date

April 22, 2022

Study Completion Date

January 27, 2025

Conditions

Aplastic Anemia

Interventions

DRUG

Eltrombopag

Tablet for oral use, once daily or Powder for oral suspension (PfOS), once daily

DRUG

hATG

Horse ATG (ATGAM) (hATG) is not considered an investigational medicinal product (IMP)

DRUG

CsA

Cyclosporine (CsA) will be by supplied as either oral capsules or oral solution, administered twice a day

Trial Locations (20)

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

27710

Duke University Medical Center, Durham

30342

Aflac Cancerand Blood Disorders Ctr, Atlanta

40002

Novartis Investigative Site, Khon Kaen

44195

Cleveland Clinic Foundation, Cleveland

48109

University of MI Health System, Ann Arbor

60611

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

72202

Arkansas Childrens Hospital, Little Rock

77030

Texas Children's Cancer and Hematology Center, Houston

80045

Childrens Hospital Colorado, Aurora

85016

Phoenix Children s Hospital, Phoenix

117198

Novartis Investigative Site, Moscow

197022

Novartis Investigative Site, Saint Petersburg

46202-5225

Indiana University, Indianapolis

02115

Childrens Hosp Boston Dept of Hematology, Boston

07601

Hackensack University Medical Center SC-2, Hackensack

Unknown

Novartis Investigative Site, Shatin

1649 035

Novartis Investigative Site, Lisbon

WC1N 3JH

Novartis Investigative Site, London