NCT06757257

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2023Sep 2028

Study Start

First participant enrolled

May 29, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

5.3 years

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Chronic Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    18 months

Study Arms (1)

fostamatinib treatmented

Drug: fostamatinib

Interventions

fostamatinibDRUG

oral administration

fostamatinib treatmented

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Tokyo and Japanese Other Cities, Japan

RECRUITING

MeSH Terms

Interventions

fostamatinib

Central Study Contacts

Kazunori Abe, director

CONTACT

0356843575rinsyousiken@pharm.kissei.co.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

May 29, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)