A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP

Completed · Phase 2

Conditions studied: Immune Thrombocytopenic Purpura (ITP)

In brief

The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.

Key facts

Study ID

NCT03524612

Run by

Novartis Pharmaceuticals

People needed

105

Starts

2018-11-02

Expected to finish

2022-10-03

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study
• Patients ≥ 18 years old
• Patients 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 < 30×10\^9/L and assessed as needing treatment (per physician's discretion

You may not qualify if…

• ITP patients previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
• Patients who relapsed more than one year after the end of first-line full course of steroid therapy
• Patients with a diagnosis of secondary thrombocytopenia
• Patients who have life threatening bleeding complications per investigator discretion
• Patients 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
• Patients who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
• Patients with hepatic impairment (Child-Pugh score > 5)
• Patients who have active malignancy
• Patients 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 Patients participating in the study
• Patients with known active or uncontrolled infections not responding to appropriate therapy
• Patients 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 Patients 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.

Where it is running

• Hematology Oncology Association of Rockland — Nyack, New York, United States
• Case Western Reserve — Cleveland, Ohio, United States
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Temuco, Araucania, Chile
• Novartis Investigative Site — Viña del Mar, Valparaiso, Chile
• Novartis Investigative Site — Caen, France
• Novartis Investigative Site — Pessac, France
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Pátrai, Greece
• Novartis Investigative Site — Bologna, BO, Italy
• Novartis Investigative Site — Trieste, TS, Italy
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan
• Novartis Investigative Site — Guadalajara, Jalisco, Mexico
• Novartis Investigative Site — Mexico City, Mexico
• Novartis Investigative Site — Muscat, Oman
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Saint Petersburg, Russia
• Novartis Investigative Site — Málaga, Andalusia, Spain
• Novartis Investigative Site — Salamanca, Castille and León, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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