Trials / Unknown
UnknownNCT02888223
Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A
Pharmacokinetic Comparison of SCT800 (B-domain Deleted Recombinant Factor VIII) With Xyntha in Previously Treated Patients With Hemophilia A: a Phase I, Open-label, Randomized, Crossover Study
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCT800 | |
| BIOLOGICAL | Xyntha |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-02-01
- Completion
- 2017-07-01
- First posted
- 2016-09-02
- Last updated
- 2016-09-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02888223. Inclusion in this directory is not an endorsement.