Trials / Unknown
UnknownNCT03947567
Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.
A Multicenter, Open, Extension Trial to Evaluate Safety and Efficacy of Recombinant Human Coagulation Factor VIII (SCT800) During Long Term Treatment in Previously Treated Patients With Severe Haemophilia A .
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of SCT800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from V1, on-demand treatment is given when bleeding episodes occur. The study period is 120 consecutive weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Coagulation FVIII | Participants received SCT800 for prophylaxis and/or on-demand treatment for 120 weeks. |
Timeline
- Start date
- 2019-07-26
- Primary completion
- 2025-04-01
- Completion
- 2025-04-01
- First posted
- 2019-05-13
- Last updated
- 2020-04-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03947567. Inclusion in this directory is not an endorsement.