Trials / Unknown
UnknownNCT03747653
A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
A Phase I, Multicentre, Open-label, Self-control Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (estimated)
- Sponsor
- Kaifeng Pharmaceutical (Group) Co., Ltd. · Industry
- Sex
- Male
- Age
- 12 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection at two dose levels in patients with hemophilia A. Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in patients with hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADVATE | Patients will be administered a single dose of ADVATE. |
| DRUG | FRSW107 | Patients will be administered a single dose of FRSW107 for Injection. |
Timeline
- Start date
- 2019-03-08
- Primary completion
- 2020-05-31
- Completion
- 2020-05-31
- First posted
- 2018-11-20
- Last updated
- 2020-05-08
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03747653. Inclusion in this directory is not an endorsement.