Iclusig PMS in CML or Ph+ALL Patients

NCT ID: NCT03709017

Last Updated: 2022-12-07

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-07

Study Completion Date

2023-06-30

Brief Summary

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This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.

Detailed Description

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Conditions

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Chronic Myeloid Leukemia Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ponatinib

Iclusig 45mg, 15mg

Intervention Type DRUG

Other Intervention Names

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Iclusig

Eligibility Criteria

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Inclusion Criteria

* Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment

Exclusion Criteria

* Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kosin University Gaspel Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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297-402-00002

Identifier Type: -

Identifier Source: org_study_id

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