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Clinical Trials/NCT03709017
NCT03709017Active, not recruitingNot Applicable

Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"

Korea Otsuka Pharmaceutical Co., Ltd.1 site in 1 country50 target enrollmentStarted: August 7, 2018Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
50
Locations
1
Primary Endpoint
The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR

Time Frame: until 14 days after last administration

Secondary Outcomes

  • The number of subjects who satisfy MCyR(at 3 months and 6 months from administration)
  • The number of subjects who satisfy CHR(at 3 months and 6 months from administration)
  • The percentage of subjects who satisfy MCyR(at 3 months and 6 months from administration)
  • The percentage of subjects who satisfy CHR(at 3 months and 6 months from administration)
  • The number of subjects who satisfy MMR(at 3 months and 6 months from administration)
  • The percentage of subjects who satisfy MMR(at 3 months and 6 months from administration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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