Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A
NCT02921945 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2016-10-03
Summary
In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A. These subjects will receive open label treatment with SCT800 for approximately 6 months for on-demand treatment.
Conditions
Interventions
- BIOLOGICAL
-
SCT800
recombinant human coagulation factor VIII
Sponsors & Collaborators
-
Sinocelltech Ltd.
lead INDUSTRY
Principal Investigators
-
Xielan Zhao, PhD · Xiangya Hospital of Centre-South University, Changsha, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-06-30
Countries
- China
Study Locations
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