A Study to Assess the Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP
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
ClinicalTrials.gov Identifier: NCT03524612
Novartis Reference Number: CETB115J2411
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
This study will assess the ability of eltrombopag to induce sustained treatment-free remission in ITP subjects who relapsed or failed to respond to an initial treatment with steroids.
There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP diagnosis, will allow a larger proportion of subjects to achieve sustained remission after tapering off drug. Clinically there is a need for a less toxic regimen that will provide responses and sustained remission with a shorter treatment interval. This trial is designed to assess this.
Interventions
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study
Subjects ≥ 18 years old
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)
Platelet count < 30×109/L and assessed as needing treatment (per physician's discretion
Exclusion Criteria:
ITP subjects previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
Subjects who relapsed more than one year after the end of first-line full course of steroid therapy
Subjects with a diagnosis of secondary thrombocytopenia
Subjects who have life threatening bleeding complications per investigator discretion
Subjects who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
Serum creatinine ≥ 1.5 mg/dL
Total bilirubin > 1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST) > 3.0 × ULN
Alanine transaminase (ALT) > 3.0 × ULN
Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
Subjects with hepatic impairment (Child-Pugh score > 5)
Subjects who have active malignancy
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
History or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study
Subjects with known active or uncontrolled infections not responding to appropriate therapy
Subjects with evidence of current alcohol/drug abuse
Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
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 Locations
Contacts
Have a question?
Call 1-999-669-6682 or email [email protected]