Iclusig PMS in CML or Ph+ALL Patients
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03709017
Collaborator
(none)
50
1
57.8
0.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
Actual Study Start Date
:
Aug 7, 2018
Anticipated Primary Completion Date
:
Jun 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2023
Outcome Measures
Primary Outcome Measures
- The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR [until 14 days after last administration]
Secondary Outcome Measures
- The number of subjects who satisfy CHR [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 MCyR [at 3 months and 6 months from administration]
- The percentage of subjects who satisfy MCyR [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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kosin University Gaspel Hospital | Busan | Korea, Republic of |
Sponsors and Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03709017
Other Study ID Numbers:
- 297-402-00002
First Posted:
Oct 17, 2018
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: