A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-25

Study Completion Date

2027-12-21

Brief Summary

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The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome Beta Thalassemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment

Luspatercept

Intervention Type DRUG

According to the approved label

Interventions

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Luspatercept

According to the approved label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult participants 19 years of age or older
* Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
* Participants who sign the informed consent form

Exclusion Criteria

* Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
* Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No