A phase II, open-label, prospective, single-arm, study to assess ability of eltrombopag to induce sustained remission in subjects with ITP who are refractory or relapsed after first-line steroids (TAPER)

ovartis Farmacéutica, S.A.0 sites101 target enrollmentAugust 7, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Farmacéutica, S.A.

•1\. Signed informed consent must be obtained prior to participation in the study
•2\. Subjects \= 18 years old
•3\. Subjects with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
•4\. Platelet count \< 30×109/L and assessed as needing treatment (per physician’s discretion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 66
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 35

•1\. ITP subjects previously treated with any ITP second\-line therapies, thrombopoietin receptor (TPO\-R) agonists for ITP, except steroids / IVIG
•2\. Subjects who relapsed more than one year after the end of first\-line full course of steroid therapy
•3\. Subjects with a diagnosis of secondary thrombocytopenia
•4\. Subjects who have life threatening bleeding complications per investigator discretion
•5\. Subjects who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
•6\. Serum creatinine \= 1\.5 mg/dL
•7\. Total bilirubin \> 1\.5 × upper limit of normal (ULN)
•8\. Aspartate transaminase (AST) \> 3\.0 × ULN
•9\. Alanine transaminase (ALT) \> 3\.0 × ULN
•10\. Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive