Special Drug Use-results Survey for Long-term Use (Fostam... | NCT06757257

Studies
Special Drug Use-results Survey for Long-term Use (Fostamatinib)

NCT06757257

Sponsor

Kissei Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jan 3, 2025Actual

Enrollment

149Estimated

Phase

Not provided

Conditions

Chronic Idiopathic Thrombocytopenic Purpura

Interventions

fostamatinib

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2023Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2028Estimated

First Submitted Date

Dec 26, 2024

First Submission Date that Met QC Criteria

Dec 26, 2024

First Posted Date

Jan 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2024

Last Update Posted Date

Jan 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

149Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fostamatinib treatmented			Drug: fostamatinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fostamatinib	Drug	oral administration	fostamatinib treatmented

Measure	Description	Time Frame
Adverse events		18 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kazunori Abe, director	Contact	0356843575		rinsyousiken@pharm.kissei.co.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site	Recruiting	Tokyo and Japanese Other Cities			Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523665	fostamatinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided