A phase III, randomized, multicenter, single-blind, placebo controlled study to compare the efficacy and safety of Anagrelide retard” versus placebo in at risk” patients with Essential Thrombocythaemia

• Conditions: male and female at risk patients with Essential Thrombocythaemia; MedDRA version: 12.1Level: LLTClassification code 10015493Term: Essential thrombocythaemia

• Registration Number: EUCTR2009-017095-24-HU
• Lead Sponsor: AOP Orphan Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• willing and able to give written informed consent prior to any study specific procedures and able to comply with this protocol
• Male or female patients aged between 18 and 60 years,
• Confirmed diagnosis of ET according to WHO-criteria (2008) including assessment of JAK-2 status.
• Presence of predisposing risk factors for ET related events confirmed by clinical or laboratory results:

- Platelet count < 1.000 G/L
additionally at least ONE of the following criteria has to be fulfilled:
- Patients aged between 40 and 60 years
or
- Patients with ET and disease duration > 3 years (Diagnosis of ET has to be at least 3 years ago and confirmed at time of screening)
or
- Patients with ONE of the following risk factors for thrombotic complications:
a)JAK- 2 positivity, b)Protein C and/or Protein S deficiency, c)Antithrombin III deficiency, d)Factor V Leiden or Prothrombin mutation, e)Cardiovascular risk factors: (Hypertension: grade 1 and 2, WHO; smoking (>5 cigarettes/d), obesity (BMI>30), cholesterol (HDL/LDL ratio < 4))

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• diagnosis of any other myeloproliferative disorder
• high-risk status (age > 60 years, platelet count = 1.000 G/L, increase of platelet count > 300 G/L within 3 month, history of thrombotic/haemorhagic or ischemic complications).
• any known cause for a secondary thrombocytosis
• previous or current treatment of ET with cytoreductive therapy
• diagnosis of any malignancy, apart from ET, within the last 3 years
• known or suspected intolerance to the investigational products
• known or suspected congestive heart failure
• WBC = 15 G/L
• severe renal impairment (creatinine clearance <30 ml/min)
• severe liver impairment (ALT or AST >5 times normal)
• clinically significant abnormal laboratory values (excluding markers of essential thrombocythaemia)
• diabetes mellitus
• infection with hepatitis B, hepatitis C or HIV
• patients with a history of drug/alcohol abuse (within the previous 2 years)
• participation in another investigational study within 6 months prior to enrolment or for a longer duration if specified in local regulations
• women of childbearing potential with inadequate contraception
• pregnant or lactating women (pregnancy test to be assessed within 7 days prior to study treatment start)
• Any significant psychiatric disorder that, in the opinion of the investigator, might prohibit the understanding and giving of informed consent or that might prevent the patient from completing the trial.

Study & Design

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