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

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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.

Condition 
Immune Thrombocytopenic Purpura (ITP)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
101 participants
Start date 
Nov 02, 2018
Completion date 
Nov 30, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
eltrombopag
eltrombopag is for oral use and comes in 12.5, 25, 50 and 75 mg tablets; prescribed dose is taken once daily

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

United States
University Of Southern California
Withdrawn
Los Angeles, 90033
California
United States
Winship Cancer Institute of Emory University
Recruiting
Atlanta, 30308
Georgia
United States
Hematology Oncology Association of Rockland Drug Shipment
Recruiting
Nyack, 10960
New York
United States
Case Western Reserve SC - 2
Recruiting
Cleveland, 44106-5000
Ohio
United States
University of Pennsylvania Health System
Recruiting
Philadelphia, 19104
Pennsylvania
United States
Houston Methodist Hospital
Recruiting
Houston, 77030
Texas
United States
Austria
Novartis Investigative Site
Recruiting
A-1090 Vienna,
-
Austria
Novartis Investigative Site
Recruiting
Linz, 4010
-
Austria
Novartis Investigative Site
Recruiting
Wien, 1140
-
Austria
Brazil
Novartis Investigative Site
Active, not recruiting
Salvador, 41253-190
BA
Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro, 20211-030
RJ
Brazil
Novartis Investigative Site
Active, not recruiting
Sao Paulo,
SP
Brazil
Chile
Novartis Investigative Site
Recruiting
Temuco, 4810469
Araucania
Chile
Novartis Investigative Site
Active, not recruiting
Vina del Mar, 2540364
Valparaiso
Chile
France
Novartis Investigative Site
Recruiting
Caen Cedex, 14033
-
France
Novartis Investigative Site
Recruiting
Creteil, 94000
-
France
Novartis Investigative Site
Active, not recruiting
Pessac Cedex, 33604
-
France
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Heraklion Crete, 711 10
-
Greece
Novartis Investigative Site
Recruiting
Patras, 265 00
-
Greece
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
BO
Italy
Novartis Investigative Site
Active, not recruiting
Trieste, 34129
TS
Italy
Japan
Novartis Investigative Site
Active, not recruiting
Nagoya-city, 466-8650
Aichi
Japan
Novartis Investigative Site
Recruiting
Shiwa-gun, 028-3695
Iwate
Japan
Novartis Investigative Site
Recruiting
Isehara, 259-1193
Kanagawa
Japan
Mexico
Novartis Investigative Site
Recruiting
Guadalajara, 44160
Jalisco
Mexico
Novartis Investigative Site
Recruiting
Ciudad de Mexico, 14000
-
Mexico
Oman
Novartis Investigative Site
Recruiting
Muscat, 123
-
Oman
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 125167
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 191024
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
Active, not recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Comunidad Valenciana
Spain
Novartis Investigative Site
Active, not recruiting
Majadahonda, 28222
Madrid
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Completed
Madrid, 28046
-
Spain
Novartis Investigative Site
Recruiting
Malaga, 29010
-
Spain
Novartis Investigative Site
Recruiting
Murcia, 30008
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Muensterlingen, 8596
CHE
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland
Novartis Investigative Site
Recruiting
Luzern, 6000
-
Switzerland
Turkey
Novartis Investigative Site
Recruiting
Aydin, 09100
-
Turkey
Novartis Investigative Site
Recruiting
Edirne, 22030
-
Turkey
Novartis Investigative Site
Active, not recruiting
Kocaeli, 41380
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Bristol, BS2 8ED
-
United Kingdom
Novartis Investigative Site
Recruiting
Glasgow, G31 2ER
-
United Kingdom
Novartis Investigative Site
Recruiting
London, E1 1BB
-
United Kingdom
Novartis Investigative Site
Recruiting
London, NW1 2BU
-
United Kingdom
Novartis Investigative Site
Recruiting
London, W12 0HS
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]