Trials / Unknown
UnknownNCT04805801
The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (estimated)
- Sponsor
- JW Pharmaceutical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.
Detailed description
Target subject : 1. Patients with Hemophilia A with FVIII inhibitors 2. Patients with severe Hemophilia A without FVIII inhibitors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Emicizumab subcutaneous injection | Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation. |
Timeline
- Start date
- 2019-08-28
- Primary completion
- 2024-07-01
- Completion
- 2025-02-01
- First posted
- 2021-03-18
- Last updated
- 2021-07-21
Locations
1 site across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04805801. Inclusion in this directory is not an endorsement.