Essential Thrombocythemia (ET)Phase 3NCT01467661
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
A Phase 3 study testing SPD422 (anagrelide hydrochloride) in people with Essential Thrombocythemia (ET), run by Shire at 16 sites in Japan.
Trial summary
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Thrombocythemia (ET)
- What is being tested?
- SPD422 (anagrelide hydrochloride)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 16 sitesJapan
- Study dates
- 27 Oct 2010to 1 May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have completed Study SPD422 308
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Akita University Hospital
Akita, Akita, 010-8543
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, 12 260-8677
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, 13 152-8902
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
Honkomagome 3-18-22, Bunkyo-ku, 13 113-8677
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1143
Juntendo University Shizuoka Hospital
Izunokuni-shi, Shizuoka, 22 410-2295
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Niigata Cancer Centre
Niigata, Niigata, 951-8566
Okayama University Hospital
Okayama, Okayama-ken, 33 700-8558
Osaka City University Hospital
Osaka, Osaka, 545-0051
Hokkaido University Hospital
Sapporo, Hokkaidō Prefecture, 01 060-8648
Nippon Medical School Hospital
Sendagi 1-1-5, Bunkyo-ku, 13 113-8603
Gunma University Hospital
Showa-machi 3-39-15, Maebashi-shi, 10 371-8511
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Keio University Hospital
Tokyo, 160-8582
Mie University Hospital
Tsu, Mie-ken, 514-8507
About this study
Official title: A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.
- Conditions
- Essential Thrombocythemia (ET)
- Being tested
- SPD422 (anagrelide hydrochloride)
- Medical subject headings
- Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD422 (anagrelide hydrochloride)Drug
Also called Xagrid, Agrylin
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
| Study group | Role | What they receive |
|---|---|---|
| SPD422 (anagrelide hydrochloride) | Experimental | Not described Receives: Drug: SPD422 (anagrelide hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Platelet Count at Final Assessment
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Measured: Baseline and final assessment (within 5 days of the last dose of investigational product)
Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Measured: Baseline and final assessment (within 5 days of the last dose of investigational product)
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.
Measured: Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.
Measured: Baseline and final assessment (within 5 days of the last dose of investigational product)
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.
Measured: Baseline and final assessment (within 5 days of the last dose of investigational product)
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.
Measured: Baseline and final assessment (within 5 days of the last dose of investigational product)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
Measured: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study start27 Oct 2010
- Primary completion1 May 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential Thrombocythemia (ET)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467661
- Sponsor's protocol ID
- SPD422-309
- Status last verified
- May 2021
- First submitted
- 31 Oct 2011
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kanakura Y, Shirasugi Y, Yamaguchi H, Koike M, Chou T, Okamoto S, Achenbach H, Wu J, Nakaseko C. A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia. Int J Hematol. 2018 Nov;108(5):491-498. doi: 10.1007/s12185-018-2510-7. Epub 2018 Aug 18.
PubMed 30121892
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
- ClinicalTrials.gov ID
- NCT01467661
- Acronym / sponsor ID
- SPD422-309
- Conditions
- Essential Thrombocythemia (ET)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2010 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Posted 8 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPD422 (anagrelide hydrochloride) | Experimental | Drug: SPD422 (anagrelide hydrochloride) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have completed Study SPD422 308
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SPD422 (anagrelide hydrochloride)Also: Xagrid, AgrylinSubjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary. | Drug | SPD422 (anagrelide hydrochloride) |
Primary outcome
Change From Baseline in Platelet Count at Final Assessment
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
Time frame: Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30121892Kanakura Y, Shirasugi Y, Yamaguchi H, Koike M, Chou T, Okamoto S, Achenbach H, Wu J, Nakaseko C. A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia. Int J Hematol. 2018 Nov;108(5):491-498. doi: 10.1007/s12185-018-2510-7. Epub 2018 Aug 18.
Related trials for Essential Thrombocythemia (ET)
Active, not recruitingPhase 2
Extended Access of Momelotinib in Adults With Myelofibrosis
Primary Myelofibrosis
Active, not recruitingPhase 2
Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Thrombocythemia, Essential
Not yet recruitingPhase 2
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Active, not recruitingPhase 3
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
Essential Thrombocythemia
Active, not recruitingPhase 1
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
Myelofibrosis, Essential Thrombocythemia
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.
Study Director study director
Takeda
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPD422 (anagrelide hydrochloride) in people with Essential Thrombocythemia (ET), run by Shire at 16 sites in Japan.
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 0 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Platelet Count at Final Assessment (time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467661, 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 9 Jun 2021.