The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 101

Inclusion Criteria

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

Exclusion Criteria

1. ITP patients previously treated with any ITP second-line therapies,
thrombopoietin receptor (TPO-R) agonists for ITP, except steroids /
IVIG
2. Patients who relapsed more than one year after the end of first-line
full course of steroid therapy
3. Patients with a diagnosis of secondary thrombocytopenia
4. Patients who are unable to participate in assessments/biological
studies
5. Patients who have life threatening bleeding complications per
investigator discretion
6. Patients who had a deep vein thrombosis or arterial thrombosis in the
6 months preceding enrollment
7. Presence of moderate to severe impaired renal function as indicated
by any or all of the following criteria:
? Creatinine clearance < 45 mL/min as calculated using Cockcroft-Gault
formula
? Serum creatinine > 1.5 mg/dL
8. Total bilirubin > 1.5 × upper limit of normal (ULN)
9. Aspartate transaminase (AST) > 3.0 × ULN
10. Alanine transaminase (ALT) > 3.0 × ULN
11. Subjects who are human immune deficiency virus (HIV), hepatitis C
virus (HCV), hepatitis B surface antigen (HBsAg) positive
12. Subjects with hepatic impairment (Child-Pugh score > 5)
13. Subjects who have active malignancy
14. Subjects with any serious and/or unstable pre-existing medical,
psychiatric disorder or other conditions that could interfere with
subject's safety, obtaining informed consent or compliance with the
study procedures per investigator discretion
15. History or current diagnosis of cardiac disease indicating significant
risk of safety for subjects participating in the study
16. Subjects with known active or uncontrolled infections not responding
to appropriate therapy
17. Subjects with evidence of current alcohol/drug abuse
18. Women of child-bearing potential and sexually active males unwilling
to use adequate contraception during the study
19. Female subjects who are nursing or pregnant (positive serum or
urine B-human chorionic gonadotrophin (B-hCG) pregnancy test) at
screening or pre-dose on Day 1
Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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