Trials / Unknown
UnknownNCT04061109
Safety, Efficacy Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
Multicenter, Noncontrol Study of Recombinant Coagulation Factor VIII for Prophylactic Therapy in Subjects With Hemophilia A.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, single-arm trial to evaluate the efficacy and safety of Recombinant Coagulation Factor VIII in patients with hemophilia A . Recombinant Coagulation Factor VIII is prophylactic administrated 25 - 35 IU/kg once every other day or three times per week which should be continuous for 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Coagulation FVIII | A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor. |
Timeline
- Start date
- 2019-05-15
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2019-08-19
- Last updated
- 2019-08-19
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04061109. Inclusion in this directory is not an endorsement.