Trials / Unknown
UnknownNCT03709017
Iclusig PMS in CML or Ph+ALL Patients
Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ponatinib | Iclusig 45mg, 15mg |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2022-11-29
- Completion
- 2023-06-01
- First posted
- 2018-10-17
- Last updated
- 2022-12-07
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03709017. Inclusion in this directory is not an endorsement.