Status:
COMPLETED
Anagrelide Retard vs. Placebo: Efficacy and Safety in "At-risk" Patients With Essential Thrombocythaemia
Lead Sponsor:
AOP Orphan Pharmaceuticals AG
Conditions:
Essential Thrombocythaemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
This is a multicenter, phase III, randomized, subject and sponsor-blinded, placebo-controlled study to determine the treatment effect of "Anagrelide retard" in subjects with Essential Thrombocythaemia...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent prior to any study specific procedures and able to comply with this protocol
- Male or female subjects aged between 18 and 60 years,
- Confirmed diagnosis of ET according to WHO-criteria 2008 (Appendix A) including assessment of JAK-2 status (central re-evaluation).
- Presence of predisposing risk factors for ET related events confirmed by clinical or laboratory results:
- Definition of subjects with potential risk for ET-related Events:
- \- Platelet count \< 1.000 G/L
- Additionally at least ONE of the following criteria has to be fulfilled:
- Subjects aged between 40 and 60 years or
- Subjects 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
- Subjects with ONE of the following risk factors for thrombotic complications:
- JAK- 2 positivity
- Protein C and/or Protein S deficiency
- Antithrombin III deficiency
- Factor V Leiden or Prothrombin mutation
- Cardiovascular risk factors:
- Essential hypertension,
- Smoking (\>5 cigarettes/d),
- Obesity (BMI\>30),
- Cholesterol (HDL/LDL ratio \< 4),
- Hormone replacement therapy,
- Hormonal contraception.
Exclusion
- 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/haemorrhagic 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 product
- 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)
- Poorly controlled diabetes mellitus
- Infection with hepatitis B, hepatitis C or HIV
- Subjects 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 subject from completing the trial.
- Women of childbearing potential with inadequate contraception; women with child-bearing potential, receiving oral hormone contraception and aiming to participate in the study, will have to apply an additional effective method of contraception during the study period; male subjects, receiving investigational medicinal product, which have sexual intercourse with females of childbearing potential, should use medically acceptable and reliable method of contraception to prevent pregnancy.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01230775
Start Date
December 1 2010
End Date
January 1 2015
Last Update
May 26 2016
Active Locations (37)
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1
Uniklinik Innsbruck
Innsbruck, Austria
2
Universitätsklinik für Innere Medizin III, Universitätsklinikum Salzburg
Salzburg, Austria
3
Hanusch Krankenhaus
Vienna, Austria
4
Sozialmedizinisches Zentrum Ost
Vienna, Austria