Trials / Unknown
UnknownNCT02930317
Evaluate Efficacy and Safety of Recombinant Factor VIII （rFVIII）Treatment of Severe or Moderately Severe Hemophilia A
An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of rFVIII in the Prevention and Treatment of Bleeding Episodes in Chinese With Hemophilia A
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia A. To determine the pharmacokinetic (PK) parameters of rFVIII.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Factor VIII (50 IU/kg) | |
| DRUG | Recombinant Factor VIII (On-demand treatment) |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-10-01
- Completion
- 2017-12-01
- First posted
- 2016-10-12
- Last updated
- 2016-10-12
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02930317. Inclusion in this directory is not an endorsement.