Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
Recruiting
Phase 3
Interventional Study
Haemophilia A
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 6
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 36 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
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About This Trial
This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male subjects with severe hemophilia A (FVIII:C \< 1% in central laboratory tests)
* previously untreated with pdFVIII/rFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).
* FV…
Contacts