D

Phase 1

• Conditions: Essential thrombocytemia; MedDRA version: 21.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002885-30-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

A patient will be eligible if all of the following criteria apply:
- age between 18 and 75 years;
- an ET diagnosis according to WHO 2008 criteria;2
- ongoing aspirin 100 mg daily since at least 1 month, according to the judgement of the referring Hematologist;
- the patient understands and voluntarily signs an 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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

A patient is not eligible if any of the following criteria apply:
- platelet count >1,000,000/µL on three occasions over the 2 months before enrolment;
- creatinine level >1.5 x upper limit of normal;
- liver disease defined as AST and/or ALT values >3 x upper limit of normal;
- BMI >35 kg/m2;
- history of major bleeding that in the referring Hematologist's judgement may expose the patient to increased risk of bleeding recurrence
- active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
- pregnancy or lactation;
- use of non-steroidal anti-inflammatory drugs (NSAIDs) >3 times/week;
- use of antiplatelet agents other than aspirin 100 mg od;
- use of oral anticoagulants including vitamin K antagonists, anti-Xa or -IIa agents;
- use of heparins or fondaparinux
- chronic use of steroids (prednisone >5 mg/die or equivalent)

Study & Design

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