Treatment of low platelets in patients suffering from Immune Thrombocytopenia with eltrombopag (oral drug) versus IVIG (intravenous immune globuline) who are in need of surgery.

Phase 1

Active, not recruiting

• Conditions: Immune thrombocytopenia patients with low platelets and in need of surgery.; MedDRA version: 19.0Level: LLTClassification code 10023095Term: ITPSystem Organ Class: 100000004851; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2016-004295-22-NL
• Lead Sponsor: Hagaziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Primary or secondary ITP (according to the ASH 2011 guidelines);
2. Platelet count below the surgical platelet count threshold (50 x109/L for minor surgery; 100
x 109/L for major surgery);
3. 18 years of age or older;
4. On stable doses of concomitant ITP medications (or no medication) for at least 2 weeks
(i.e. the dose administered has not changed);
5. At least 3-weeks lead time available between randomization and scheduled surgery;
6. IVIG and Eltrombopag are acceptable ITP treatment options for this patient;
7. Able to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Pregnancy or breastfeeding;
2. Treatment with IVIG within the last 2 weeks;
3. Treatment with a thrombopoietin receptor agonist (eltrombopag or romiplostim) within the
last 4 weeks;
4. AST, ALT above 2X upper limit of normal;
5. Bilirubin above 1.5X upper limit of normal in the absence of clinically benign liver disorder
(e.g. Gilberts syndrome);
6. Deep vein thrombosis, myocardial infarction, thrombotic stroke or arterial thrombosis in the
last 12 months;
7. History of bone marrow reticulin or fibrosis;
8. Known liver cirrhosis;
9. Active malignancy (defined as requiring treatment or palliation within the last 6 months).
10. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified