Status:
COMPLETED
A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The purpose of this study was 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-diag...
Detailed Description
This is a Phase II, multicenter, 1:1 randomized, open-label study that compared the efficacy and safety of eltrombopag in combination with a short course of high-dose dexamethasone to 1-3 cycles of hi...
Eligibility Criteria
Inclusion
- Signed informed consent must be obtained prior to participation in the study.
- Men and women ≥ 18 years of age
- Newly diagnosed with primary ITP (time from diagnosis within 3 months)
- 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
- Previous history of treatment for ITP, except any ITP-directed therapy for a maximum of 3 days within 7 days before randomization
- Patients with diagnosis of secondary thrombocytopenia
- Patients who have life threatening bleeding complications per physician´s discretion
- Patients with a history of thromboembolic events in the 6 months preceding enrollment or known risk factors for thromboembolism
- Serum creatinine \> 1.5 mg/dL
- Total bilirubin (TBIL) \> 1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST) \> 3.0 × ULN
- Alanine transaminase (ALT) \> 3.0 × ULN
- Patients who are human immune deficiency virus (HIV),hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) positive
- Patients with hepatic impairment (Child-Pugh score \> 5)
- Patients with known active or uncontrolled infections not responding to appropriate therapy
- History of current diagnosis of cardiac disease or impaired cardiac function denoted
- Patients who have active malignancy
- Patients with evidence of current alcohol/drug abuse
- 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
- 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
- Women of child-bearing potential and males unwilling to use adequate contraception during the study
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04346654
Start Date
October 9 2020
End Date
September 22 2023
Last Update
May 16 2025
Active Locations (10)
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1
Novartis Investigative Site
Aschaffenburg, Bavaria, Germany, 63739
2
Novartis Investigative Site
Aachen, Germany, 52074
3
Novartis Investigative Site
Chemnitz, Germany, 09113
4
Novartis Investigative Site
Donauwörth, Germany, 86609