Chronic Idiopathic Thrombocytopenic PurpuraNCT06757257
Special Drug Use-results Survey for Long-term Use (Fostamatinib)
An observational study of Chronic Idiopathic Thrombocytopenic Purpura, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Idiopathic Thrombocytopenic Purpura
- What is being tested?
- fostamatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 149 participants
- Where
- 1 siteJapan
- Study dates
- 29 May 2023to 30 Sep 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
Who may be able to join
- Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Research site
Tokyo and Japanese Other Cities
Kazunori Abe, director, 0356843575, rinsyousiken@pharm.kissei.co.jp
About this study
The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.
Read the detailed description
The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.
- Being tested
- fostamatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fostamatinibDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| fostamatinib treatmented | Not described Receives: Drug: fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start29 May 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Thrombocytopenic PurpuraStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757257
- Sponsor's protocol ID
- TLPMS01
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use-results Survey for Long-term Use (Fostamatinib)
- ClinicalTrials.gov ID
- NCT06757257
- Acronym / sponsor ID
- TLPMS01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Jan 2025 (actual)
- 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.
The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.
Detailed description
The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fostamatinib treatmented | – | Drug: fostamatinib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
Key inclusion criteria (1 listed)
- Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.
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 |
|---|---|---|
| fostamatiniboral administration | Drug | fostamatinib treatmented |
Primary outcome
Adverse events
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Idiopathic Thrombocytopenic Purpura, run by Kissei Pharmaceutical Co., Ltd. at 1 site 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazunori Abe, director (0356843575, rinsyousiken@pharm.kissei.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 18 months). 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 3 Jan 2025.