Essential ThrombocythaemiaPhase 3ARETANCT01230775
Anagrelide Retard vs. Placebo: Efficacy and Safety in "At-risk" Patients With Essential Thrombocythaemia
A Phase 3 study testing Anagrelide retard in people with Essential Thrombocythaemia, run by AOP Orphan Pharmaceuticals AG at 37 sites in 9 countries.
Trial 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 (ET) at "defined risk" (definition of risk criteria: see Inclusion Criteria Section 5.1) The study is planned as a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Essential Thrombocythaemia
- What is being tested?
- Anagrelide retard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 37 sitesin 9 countries
- Study dates
- Dec 2010to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
37 sites in 9 countries.
37 sites in 9 countries
Poland6 sites
Uniwersyteckie Centrum Kliniczne
Gdansk
SP Szpital Kliniczny im. A. Mieleckiego
Katowice
Wojewódzki Szpital Specjalistyczny
Rzeszów
Specjalistyczny Szpital Miejski
Torùn
Klinika Hematologiczna, Instytut Hematologii i Transfuzjologii
Warsaw
Samodzielny Publiczny Centralny Szpital
Warsaw
Romania6 sites
Clinical County Hospital "Dr. Constantin Opris"
Baia Mare
"Coltea" Clinic Hospital
Bucharest
"Fundeni" Clinical Institute
Bucharest
University Emergency Hospital
Bucharest
Emergency County Clinic Hospital
Sibiu
Emergency County Hospital Târgu Mureș
Târgu Mureş
Russia6 sites
State Medical Institution Territorial Clinical
Krasnodar
Haematology Research Center of RAMS
Moscow
Leningrad Regional Clinical Hospital
Saint Petersburg
Russian scientific Research Institute for Hematology and Transfusiology
Saint Petersburg
Saint Petersburg State Institution of Healthcare
Saint Petersburg
Yaroslavl Regional Clinical Hospital
Yaroslavl
Austria5 sites
Uniklinik Innsbruck
Innsbruck
Universitätsklinik für Innere Medizin III, Universitätsklinikum Salzburg
Salzburg
Hanusch Krankenhaus
Vienna
Sozialmedizinisches Zentrum Ost
Vienna
Uniklinik für Innere Medizin I
Vienna
Bulgaria5 sites
University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski"
Pleven
University Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv
Multiprofile Hospital for Active Treatment, "Tokuda Hospital Sofia"
Sofia
National Specialized Hospital for Active Treatment of Hematological Diseases
Sofia
SHAT "Joan Pavel"
Sofia
Ukraine5 sites
Institute of Urgent and Recovery Surgery n.a.
Donetsk
Kmelnitskiy Regional Hospital
Khmelnitskiy
Institute of Haematology and Transfusiology
Kiev
Scientific Center of Radiation Medicine AMS of Ukraine
Kiev
Lviv Blood Pathology Institute
Lviv
Lithuania2 sites
Kauno Medicinos Universiteto Klinikos
Kaunas
Klaipeda Hospital
Klaipėda
About this study
Official title: A Phase III, Randomized, Multicenter, Subject and Sponsor-blinded, Placebo Controlled Study to Compare the Efficacy and Safety of "Anagrelide Retard" Versus Placebo in "at Risk" Subjects With Essential Thrombocythaemia
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 (ET) at "defined risk" (definition of risk criteria: see Inclusion Criteria Section 5.1) The study is planned as a 2-stage procedure according to Bauer and Köhne: After recruitment of 140 subjects an interim analysis with re-assessment of sample size is planned in an adaptive manner.
As the confirmatory analysis will be based on a time-to-event evaluation (i.e. time to 1st clinically significant ET related event), there is no stipulated observation time identically applying for all subjects. Yet, with an interim analysis being performed after having recruited 140 subjects - which is expected to be reached after 1 year - the estimated observation time for a subject in stage I will also be about 1 year. (Details are explained in the section "Statistical Considerations").
Read more
Subjects will be randomized in a 1:1 ratio to one of the following two arms:
Group A: Anagrelide retard Group B: Placebo
An a priori stratification is planned for the JAK-2 mutational status. For exploratory purposes a post hoc stratification is used for obtaining covariate adjusted results, for the following other potentially predictive factors: sex, age, Factor V Leiden, and BMI.
Dosing will be started with 1 tablet per day for week 1 and will be titrated up according to response (platelet reduction) to 2 tablets in week 2. Dosing may be further increased or decreased according to platelet response in week 3 and 4. However, the maximum dose is 4 tablets (=8mg) per day. After week 4, the maximum dose to achieve optimal platelet counts (<450 G/L) should be maintained (for visit schedule see study flow chart section IV).
To verify a treatment response, platelet counts must be evaluated at every visit. The platelet count values will be withheld from the subjects for the duration of stage I or stage II respectively. The subjects have to agree explicitly to this procedure by signing the Informed Consent form.
This is a patient and sponsor-blinded clinical study. The trial medical is packaged in the blinded fashion to keep the patient unaware (blinded) towards the actual treatment group they were randomized to. The sponsor functions (including medical monitor, pharmacovigilance manager, clinical project manager, trial data manager and trial statistician) with stay blinded in the course of the study until the database lock. Randomization scheme will be prepared by an independent statistician (not otherwise involved in the study), and will be stored securely with no access to it by the sponsor functions mentioned above. The process of randomization (provision of the individual drug-allocation information to the subjects) will be carried out by a trained staff by Harrison, in adherence to the procedures to keep the other blinded functions unaware of this information (blinded). Unblinding envelopes, which contain the treatment code per patient number for identification of treatment in case when a safety-relevant unblinding needed, will be stored at the sponsor's site. At the end of the study, verification of the extent of maintaining the blind by checking if the envelopes have been broken, will take place and will be properly documented. If the sealed envelope will broken to provide treatment identification, the date of breaking the code, the initials of the person who broke the code and the reason will be stated on the envelope.
The operational details on the blinding procedures are outlined in the relevant working guidelines (ARETA Study Working Guideline for idv staff and ARETA Study Working Guideline for Harrison, each in its current version).
Investigator will not be blinded in this study, i.e. in case of a medical need individual patient management will be driven by the full knowledge of the trial related interventions. For the case, the sponsor will need to unblind a patient (e.g. due to safety reasons), the above mentioned (in this section) envelopes will be used.
Only treatment naïve subjects, in respect to cytoreductive drugs with confirmed diagnosis of ET (centralized re-evaluation according to WHO, 2008; see Section 6.2.1) and assessment of JAK-2 status (centralized re-evaluation of JAK-2 status; see Section 6.2.2) will be enrolled.
As described above, stage I of the study will be considered as closed as soon as 140 subjects have been recruited. The duration of stage II depends on the result of the re-assessment of sample size.
Once stage I is finished, stage I subjects will enter into an extension period for a maximum of three years.
- Conditions
- Essential Thrombocythaemia
- Being tested
- Anagrelide retard, Placebo
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anagrelide retardDrug
Week 1:
1x1 tablet/d of "Anagrelide retard" (1 tablet = 2mg; total dose = 2mg/d) will be administered in week 1.
Week 2 "Anagrelide retard": Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2.
Week 3 - Week 4 "Anagrelide retard" In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day.
Maintenance Phase "Anagrelide retard" During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range.
PlaceboDrug
Week 1:
- x1 tablet/d of placebo will be administered in week 1. Week 2 Placebo:
- x1 tablet/d of placebo will be administered in week 2.
Week 3 - Week 4
Placebo:
In week 3 and week 4 the maximum dose is 4 tablets per day.
Placebo:
In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period:
Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/
| Study group | Role | What they receive |
|---|---|---|
| Anagrelide retard | Experimental | Week 1:
1x1 tablet/d of "Anagrelide retard" (1 tablet = 2mg; total dose = 2mg/d will be administered in week 1.
Week 2 "Anagrelide retard": Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2.
Week 3 - Week 4 "Anagrelide retard" In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day.
Maintenance Phase "Anagrelide retard" During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range.
Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/d Receives: Drug: Anagrelide retard |
| Placebo | Placebo comparator | Week 1:
1. x1 tablet/d of Placebo will be administered in week 1.
Placebo:
2. x1 tablet/d of placebo will be administered in week 2.
Placebo:
In week 3 and week 4 the maximum dose is 4 tablets per day.
Placebo:
In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period:
Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/d Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1st clinically significant ET related event
Measured: beginning 2012
Secondary outcomes (1)
Efficacy and safety
Efficacy
- reduction of platelet counts
- occurrence of change to "high risk" status (i.e. platelets > 1.000 G/L or occurrence of an ET related event)
- number of subjects achieving a complete response
Safety
- Adverse Events
- cardiovascular safety (assessed by ECG, ECHO, NT-proBNP or BNP)
Quality of Life: SF-36
Measured: end 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential ThrombocythaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Grohmann-Izay, MD, Study director, AOP Orphan Pharmaceuticals AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230775
- Sponsor's protocol ID
- AOP13007
- Acronym
- ARETA
- Status last verified
- May 2016
- First submitted
- 28 Oct 2010
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicenter, Subject and Sponsor-blinded, Placebo Controlled Study to Compare the Efficacy and Safety of "Anagrelide Retard" Versus Placebo in "at Risk" Subjects With Essential Thrombocythaemia
- ClinicalTrials.gov ID
- NCT01230775
- Acronym / sponsor ID
- ARETA / AOP13007
- Conditions
- Essential Thrombocythaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- AOP Orphan Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (ET) at "defined risk" (definition of risk criteria: see Inclusion Criteria Section 5.1) The study is planned as a 2-stage procedure according to Bauer and Köhne: After recruitment of 140 subjects an interim analysis with re-assessment of sample size is planned in an adaptive manner.
As the confirmatory analysis will be based on a time-to-event evaluation (i.e. time to 1st clinically significant ET related event), there is no stipulated observation time identically applying for all subjects. Yet, with an interim analysis being performed after having recruited 140 subjects - which is expected to be reached after 1 year - the estimated observation time for a subject in stage I will also be about 1 year. (Details are explained in the section "Statistical Considerations").
Subjects will be randomized in a 1:1 ratio to one of the following two arms:
Group A: Anagrelide retard Group B: Placebo
An a priori stratification is planned for the JAK-2 mutational status. For exploratory purposes a post hoc stratification is used for obtaining covariate adjusted results, for the following other potentially predictive factors: sex, age, Factor V Leiden, and BMI.
Dosing will be started with 1 tablet per day for week 1 and will be titrated up according to response (platelet reduction) to 2 tablets in week 2. Dosing may be further increased or decreased according to platelet response in week 3 and 4. However, the maximum dose is 4 tablets (=8mg) per day. After week 4, the maximum dose to achieve optimal platelet counts (<450 G/L) should be maintained (for visit schedule see study flow chart section IV).
To verify a treatment response, platelet counts must be evaluated at every visit. The platelet count values will be withheld from the subjects for the duration of stage I or stage II respectively. The subjects have to agree explicitly to this procedure by signing the Informed Consent form.
This is a patient and sponsor-blinded clinical study. The trial medical is packaged in the blinded fashion to keep the patient unaware (blinded) towards the actual treatment group they were randomized to. The sponsor functions (including medical monitor, pharmacovigilance manager, clinical project manager, trial data manager and trial statistician) with stay blinded in the course of the study until the database lock. Randomization scheme will be prepared by an independent statistician (not otherwise involved in the study), and will be stored securely with no access to it by the sponsor functions mentioned above. The process of randomization (provision of the individual drug-allocation information to the subjects) will be carried out by a trained staff by Harrison, in adherence to the procedures to keep the other blinded functions unaware of this information (blinded). Unblinding envelopes, which contain the treatment code per patient number for identification of treatment in case when a safety-relevant unblinding needed, will be stored at the sponsor's site. At the end of the study, verification of the extent of maintaining the blind by checking if the envelopes have been broken, will take place and will be properly documented. If the sealed envelope will broken to provide treatment identification, the date of breaking the code, the initials of the person who broke the code and the reason will be stated on the envelope.
The operational details on the blinding procedures are outlined in the relevant working guidelines (ARETA Study Working Guideline for idv staff and ARETA Study Working Guideline for Harrison, each in its current version).
Investigator will not be blinded in this study, i.e. in case of a medical need individual patient management will be driven by the full knowledge of the trial related interventions. For the case, the sponsor will need to unblind a patient (e.g. due to safety reasons), the above mentioned (in this section) envelopes will be used.
Only treatment naïve subjects, in respect to cytoreductive drugs with confirmed diagnosis of ET (centralized re-evaluation according to WHO, 2008; see Section 6.2.1) and assessment of JAK-2 status (centralized re-evaluation of JAK-2 status; see Section 6.2.2) will be enrolled.
As described above, stage I of the study will be considered as closed as soon as 140 subjects have been recruited. The duration of stage II depends on the result of the re-assessment of sample size.
Once stage I is finished, stage I subjects will enter into an extension period for a maximum of three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anagrelide retard | Experimental | Drug: Anagrelide retardWeek 1: 1x1 tablet/d of "Anagrelide retard" (1 tablet = 2mg; total dose = 2mg/d will be administered in week 1. Week 2 "Anagrelide retard": Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2. Week 3 - Week 4 "Anagrelide retard" In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day. Maintenance Phase "Anagrelide retard" During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range. Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/d |
| Placebo | Placebo comparator | Drug: PlaceboWeek 1: 1. x1 tablet/d of Placebo will be administered in week 1. Placebo: 2. x1 tablet/d of placebo will be administered in week 2. Placebo: In week 3 and week 4 the maximum dose is 4 tablets per day. Placebo: In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period: Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/d |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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:
- Platelet count < 1.000 G/L
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anagrelide retardWeek 1: 1x1 tablet/d of "Anagrelide retard" (1 tablet = 2mg; total dose = 2mg/d) will be administered in week 1. Week 2 "Anagrelide retard": Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2. Week 3 - Week 4 "Anagrelide retard" In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day. Maintenance Phase "Anagrelide retard" During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range. | Drug | Anagrelide retard |
| PlaceboWeek 1: 1. x1 tablet/d of placebo will be administered in week 1. Week 2 Placebo: 2. x1 tablet/d of placebo will be administered in week 2. Week 3 - Week 4 Placebo: In week 3 and week 4 the maximum dose is 4 tablets per day. Placebo: In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period: Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/ | Drug | Placebo |
Primary outcome
Time to 1st clinically significant ET related event
Time frame: beginning 2012
1 secondary outcome
Efficacy and safety
Time frame: end 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Grohmann-Izay, MD study director
AOP Orphan Pharmaceuticals AG
37 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anagrelide retard in people with Essential Thrombocythaemia, run by AOP Orphan Pharmaceuticals AG at 37 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Poland, Romania, Russia, Austria, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 1st clinically significant ET related event (time frame: beginning 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.