Trials / Completed
CompletedNCT04565236
A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A
A Post Approval Commitment Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of KOVALTRY in Chinese Children, Adolescents /Adults With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 0 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to gather more information on safety and efficacy of Kovaltry for the prevention and treatment of bleeds in Chinese children, adolescents/adults with severe hemophilia A. In addition, pharmacokinetic parameters of Kovaltry will be assessed in a subset of patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1 | 25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day according to individual requirements for 6 months. The dose decisions are at the discretion of the investigator. |
| BIOLOGICAL | Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2 | 12 year-old: 25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day for 6 months. \>12 year-old: 20 to 40 IU of Kovaltry per kg of body weight given via intravenous (IV) infusion two or three times per week for 6 months. The dose decisions are at the discretion of the investigator. |
| BIOLOGICAL | Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3 | 15 to 50 IU of Kovaltry per kg body weight (minimum dose: 250 IU) given via intravenous (IV) infusions at least once a week. The dose decisions are at the discretion of the investigator. |
Timeline
- Start date
- 2020-09-22
- Primary completion
- 2024-03-15
- Completion
- 2024-03-15
- First posted
- 2020-09-25
- Last updated
- 2025-04-18
- Results posted
- 2025-04-18
Locations
10 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04565236. Inclusion in this directory is not an endorsement.