Overview
A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP
Status:
Recruiting
Recruiting
Trial end date:
2023-12-31
2023-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare the ability of eltrombopag in combination with a short course of high-dose dexamethasone to induce sustained response off treatment in patients with newly-diagnosed ITP versus 1-3 cycles of dexamethasone monotherapy. The unmet clinical need and the potential for eltrombopag when added to steroids to improve the treatment outcome and the potential to induce sustained response off treatment serve as the basis for clinical investigation of eltrombopag in first-line ITP.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Dexamethasone
Criteria
Inclusion Criteria:1. Signed informed consent must be obtained prior to participation in the study.
2. Men and women ≥ 18 years of age
3. Newly diagnosed with primary ITP (time from diagnosis within 3 months)
4. Platelet count < 30 × 109/L at screening and a need for treatment (per physician's
discretion) Note: If pre-treatment is necessary, platelet count data performed
directly before pre-treatment (can be used for study inclusion (screening value).
Treatment-naïve patients will be included based on their platelet counts performed at
screening
Exclusion Criteria:
1. Previous history of treatment for ITP, except any ITP-directed therapy for a maximum
of 3 days within 7 days before randomization
2. Patients with diagnosis of secondary thrombocytopenia
3. Patients who have life threatening bleeding complications per physician´s discretion
4. Patients with a history of thromboembolic events or known risk factors for
thromboembolism
5. Serum creatinine > 1.5 mg/dL
6. Total bilirubin (TBIL) > 1.5 × upper limit of normal (ULN)
7. Aspartate transaminase (AST) > 3.0 × ULN
8. Alanine transaminase (ALT) > 3.0 × ULN
9. Patients who are human immun deficiency virus (HIV),hepatitis C virus (HCV) or
hepatitis B surface antigen (HBsAg) positive
10. Patients with hepatic impairment (Child-Pugh score > 5)
11. Patients with known active or uncontrolled infections not responding to appropriate
therapy
12. History of current diagnosis of cardiac disease or impaired cardiac function denoted
13. Patients who have active malignancy
14. Patients with evidence of current alcohol/drug abuse
15. 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
18. 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 19. Women of
child-bearing potential and males unwilling to use adequate contraception during the study