Essential ThrombocythaemiaPhase 3ANAHYDRETNCT01065038
Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
A Phase 3 study testing Anagrelide and Hydroxyurea in people with Essential Thrombocythaemia, run by AOP Orphan Pharmaceuticals AG at 24 sites in 10 countries.
Trial summary
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points: ET is a rare disease and recruitment of large patient number (> 1600)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Thrombocythaemia
- What is being tested?
- Anagrelide and Hydroxyurea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 24 sitesin 10 countries
- Study dates
- Sep 2002to not given
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Presence of essential thrombocythaemia with high-risk profile.
Who cannot join
- previous treatment with cytoreductive drugs or Anagrelide
- pregnant women or women in childbearing age with inadequate contraception
- patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients
- known lactose intolerance
- cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio
- severe renal disease (Creatinin Clearance < 30 ml/min)
- severe liver disease (AST or ALT > 5-times normal)
- coexisting, malignant, systemic diseases
Trial locations and contacts
24 sites in 10 countries.
24 sites in 10 countries
Poland6 sites
Center Gdansk
Gdansk, 80-211
Center Katowice
Katowice, 40-027
Center Krakow
Krakow, 31-501
Center Lodz
Lodz, 93-510
Center Lublin
Lublin, 20-079
Center Warszawa
Warsaw, 02-097
Germany5 sites
Center Berlin
Berlin, 12200
Center Halle
Halle, 06111
Center Munich
Munich, Bavaria, 80331
Center Saarbrücken
Saarbrücken, 66113
Center Ulm
Ulm, 89081
Austria3 sites
Center Innsbruck
Innsbruck, Tyrol, 6020
Center AKH
Vienna, State of Vienna, 1090
Center Hanusch
Vienna, State of Vienna, 1140
Czechia3 sites
Center Brno
Brno, 62500
Center Olomouc
Olomouc, 77520
Center Praha
Prague, 12808
About this study
Official title: A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points:
- ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible.
. It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.
- Conditions
- Essential Thrombocythaemia
- Being tested
- Anagrelide, Hydroxyurea
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnagrelideDrug
HydroxyureaDrug
| Study group | Role | What they receive |
|---|---|---|
| Anagrelide | Experimental | Not described Receives: Drug: Anagrelide |
| Hydroxyurea | Active comparator | Not described Receives: Drug: Hydroxyurea |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
Sponsor and investigators
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065038
- Sponsor's protocol ID
- AOP03007
- Acronym
- ANAHYDRET
- Status last verified
- Sep 2005
- First submitted
- 8 Feb 2010
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.
PubMed 23315161
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia
- ClinicalTrials.gov ID
- NCT01065038
- Acronym / sponsor ID
- ANAHYDRET / AOP03007
- Conditions
- Essential Thrombocythaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AOP Orphan Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- First posted
- 9 Feb 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.
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points:
- ET is a rare disease and recruitment of large patient number (> 1600) to prove superiority was not considered possible.
. It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anagrelide | Experimental | Drug: Anagrelide |
| Hydroxyurea | Active comparator | Drug: Hydroxyurea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of essential thrombocythaemia with high-risk profile.
Key exclusion criteria (8 listed)
- previous treatment with cytoreductive drugs or Anagrelide
- pregnant women or women in childbearing age with inadequate contraception
- patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients
- known lactose intolerance
- cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio
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 | Drug | Anagrelide |
| Hydroxyurea | Drug | Hydroxyurea |
Primary outcome
Not reported in the source record.
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 6 Oct 2010.
- Derived from this study: PubMed 23315161Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anagrelide and Hydroxyurea in people with Essential Thrombocythaemia, run by AOP Orphan Pharmaceuticals AG at 24 sites in 10 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 1 inclusion and 8 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 6 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, Germany, Austria, Czechia, Italy and 5 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065038, which also lists 1 linked publication.
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 6 Oct 2010.