Skip to main content
MedPathMedPath Home
Clinical Trials/NCT03709017
NCT03709017
Active, not recruiting
Not 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 enrollmentAugust 7, 2018
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsChronic Myeloid LeukemiaPhiladelphia Chromosome-positive Acute Lymphoblastic Leukemia
DrugsPonatinib

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Myeloid Leukemia
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 7, 2018
End Date
June 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
Post Marketing Surveillance for ADACEL™ in South KoreaDiphtheriaTetanusPertussis
NCT01137435Sanofi Pasteur, a Sanofi Company659
Completed
Not Applicable
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)Hepatitis A
NCT01838070Sanofi Pasteur, a Sanofi Company614
Completed
Not Applicable
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 DisorderSchizophreniaBipolar 1 Disorder
NCT03386851Korea Otsuka Pharmaceutical Co., Ltd.1,030
Completed
Not Applicable
Eliquis Regulatory Post Marketing Surveillance (rPMS)Venous Thromboembolism
NCT01885585Bristol-Myers Squibb100
Completed
Not Applicable
ABF Tourette's Disorder Post Marketing Surveillance StudyTourette's Disorder
NCT01795105Korea Otsuka Pharmaceutical Co., Ltd.692