Essential Thrombocythemia (ET)Phase 3NCT01214915
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
A Phase 3 study testing Anagrelide Hydrochloride in people with Essential Thrombocythemia (ET), run by Shire at 19 sites in Japan.
Trial summary
The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. 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?
- Anagrelide Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 19 sitesJapan
- Study dates
- 27 Oct 2010to 24 Oct 2012
- 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 previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.
Who cannot join
- Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Akita University Hospital
Akita, Akita, 05 010-8543
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, 12 260-8677
Niigata Cancer Center Hospital
Chuo-ku Kawagishi-cho 2-15-3, Niigata-shi, 15 951-8566
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, 13 152-8902
Juntendo University Hospital
Hongo 3-1-3, Bunkyo-ku, 13 113-8431
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
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Juntendo University Shizuoka Hospital
Nagaoka, Izunokuni-shi, 22 410-2295
NHO Nagoya Medical Center
Nagoya, Chubu, 23 460-0001
Okayama University Hospital
Okayama, Okayama-ken, 33 700-8558
Osaka City University Hospital
Osaka, Kansai, 27 545-8586
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, 27 565-0871
Tokushima University Hospital
Tokushima, Tokushima Perfecture, 770-8503
Keio University Hospital
Tokyo, 13 160-8582
Mie University Hospital
Tsu, Mie-ken, 514-8507
About this study
Official title: A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment
The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.
- Conditions
- Essential Thrombocythemia (ET)
- Being tested
- 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.
Anagrelide HydrochlorideDrug
Also called SPD422
Subjects will be started at 1.0 mg per day and titrated as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Anagrelide Hydrochloride | Experimental | Not described Receives: Drug: Anagrelide Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Responded in Platelet Count
A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Measured: 12 months
Secondary outcomes (4)
Percentage of Subjects With at Least 50% Reduction in Platelet Count
Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.
Measured: 12 months
Percentage of Subjects With Normalization in Platelet Count
Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Measured: 12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Measured: 12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study start27 Oct 2010
- Primary completion24 Oct 2012
- Study completion24 Oct 2012
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
- 53 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
- NCT01214915
- Sponsor's protocol ID
- SPD422-308
- Status last verified
- May 2021
- First submitted
- 4 Oct 2010
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kanakura Y, Miyakawa Y, Wilde P, Smith J, Achenbach H, Okamoto S. Phase III, single-arm study investigating the efficacy, safety, and tolerability of anagrelide as a second-line treatment in high-risk Japanese patients with essential thrombocythemia. Int J Hematol. 2014 Oct;100(4):353-60. doi: 10.1007/s12185-014-1631-x. Epub 2014 Aug 27.
PubMed 25160063
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, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment
- ClinicalTrials.gov ID
- NCT01214915
- Acronym / sponsor ID
- SPD422-308
- Conditions
- Essential Thrombocythemia (ET)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2010 (actual)
- Primary completion
- 24 Oct 2012 (actual)
- Study completion
- 24 Oct 2012 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 25 Sep 2013
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 investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anagrelide Hydrochloride | Experimental | Drug: 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 previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy.
Key exclusion criteria (1 listed)
- Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with the study medication.
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 HydrochlorideAlso: SPD422Subjects will be started at 1.0 mg per day and titrated as necessary. | Drug | Anagrelide Hydrochloride |
Primary outcome
Percentage of Subjects Who Responded in Platelet Count
Time frame: 12 months
A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
4 secondary outcomes
Percentage of Subjects With at Least 50% Reduction in Platelet Count
Time frame: 12 months
Percentage of Subjects With Normalization in Platelet Count
Time frame: 12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L
Time frame: 12 months
Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L
Time frame: 12 months
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 25160063Kanakura Y, Miyakawa Y, Wilde P, Smith J, Achenbach H, Okamoto S. Phase III, single-arm study investigating the efficacy, safety, and tolerability of anagrelide as a second-line treatment in high-risk Japanese patients with essential thrombocythemia. Int J Hematol. 2014 Oct;100(4):353-60. doi: 10.1007/s12185-014-1631-x. Epub 2014 Aug 27.
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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.
Study Director study director
Takeda
19 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 Anagrelide Hydrochloride in people with Essential Thrombocythemia (ET), run by Shire at 19 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 1 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 19 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 25 Sep 2013). 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?
Percentage of Subjects Who Responded in Platelet Count (time frame: 12 months). 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 NCT01214915, 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.