Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.
ConditionHaemophilia A
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
AgeUp to 6
SponsorSinocelltech Ltd.
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.
Eligibility criteria
Qualifiers
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).
FVIII inhibitor negative
informed consent.
Disqualifiers
Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
subjects with a history or family history of FVIII inhibitor formation;
Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;
Patients with other coagulation dysfunction diseases in addition to hemophilia A.
Trial design
Treatments tested in this trial
- SCT800 prophylaxis and treatment for bleeding events
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov