Trials / Completed
CompletedNCT06137092
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
A Randomized, Two-armed, Double-blind, Single-dose, Crossover, Two-sequence, Bioequivalence Clinical Trial to Compare PK Parameters and Safety of rFVIII-Fc (AryoGen Pharmed Co.) Versus Elocta® in PTPs With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- AryoGen Pharmed Co. · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) | rFVIII-Fc, IV, 50 units/kg/ single dose, cross-over |
Timeline
- Start date
- 2023-07-22
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
- First posted
- 2023-11-18
- Last updated
- 2023-11-18
Locations
5 sites across 1 country: Iran
Source: ClinicalTrials.gov record NCT06137092. Inclusion in this directory is not an endorsement.