A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to investigate if eltrombopag can be used instead of Intravenous Immune Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery have to get treatment to increase their platelet count. IVIG is commonly used for this purpose but eltrombopag may be more effective and convenient for patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: GlaxoSmithKline; Hamilton Health Sciences Corporation; Novartis
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Primary or secondary ITP;

• Platelet count below surgical platelet count threshold (50 x10^9/L for minor surgery; 100 x 10^9/L for major surgery);

• 18 years of age or older;

• On stable doses of concomitant ITP medications (i.e the dose administered has not changed) or no ITP medication for at least 2 weeks;

• At least 3-weeks lead time available between randomization and scheduled surgery;

• IVIG and Eltrombopag are acceptable ITP treatment options for this patient;

• Able to provide informed consent.

Exclusion Criteria:

• Pregnancy or breastfeeding;

• Treatment with IVIG within the last 2 weeks;

• Treatment with a thrombopoietin receptor agonist (eltrombopag or romiplostim) within the last 4 weeks;

• AST, ALT above 2X upper limit of normal;

• Bilirubin above 1.5X upper limit of normal in the absence of clinically benign liver disorder (eg. Gilberts syndrome);

• Deep vein thrombosis, myocardial infarction, thrombotic stroke or arterial thrombosis in the last 12 months;

• History of bone marrow reticulin or fibrosis;

• Known liver cirrhosis;

• Active malignancy (defined as requiring treatment or palliation within the last 6 months);

• Any additional laboratory test result, health related illness or other diagnosis which, in the opinion of the treating physician, may put the subject's health or safety at risk.