A Phase I of SS109 in Hemophilia A or and B With Inhibitors (NCT05651061) | Clinical Trial Compass
CompletedPhase 1
A Phase I of SS109 in Hemophilia A or and B With Inhibitors
China27 participantsStarted 2022-12-14
Plain-language summary
This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. All patients included in the study will continue to be followed up until 28 days after SS109 administration.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Age was 18 to 65 years old，when signing the informed consent form, male;
✓. Clinical diagnosis of hemophilia A or B (previous or screening period FⅧ activity level≤ 1% or FⅨ activity level≤ 2%), and there is one of the following conditions:
✓. No active bleeding symptoms before the first injection;
✓. Patients can comply with the requirements of the protocol and be willing to complete the study as planned and provide biological samples for test;
✓. Be able to understand the procedures and methods of this clinical trial. The patient voluntarily participates and signs by himself or by the impartial witness
Exclusion criteria
✕. Patients with known history of hypersensitivity to the investigational drug preparation and any of its components;
✕. There was hypersensitivity or anaphylaxis after FⅦ or IgG2 injection treatment in the past;
✕. Patients with FⅦ inhibitor positive or with FⅦ inhibitor positive history in screening period;
✕. Severe anemia (hemoglobin \< 60g/L);
✕. Platelet count \< 100 × 109/L；
✕. Patients with abnormal liver and kidney functions: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ 2.5 times the upper limit of normal value (ULN), or total bilirubin ≥ 1.5 times ULN; or blood creatinine (Cr) ≥ 1.5 times;
What they're measuring
1
The incidence of adverse event/serious adverse event/specical interest adverse event(AE/SAE/AESI)
Timeframe: Up to 28 days after SS109 injected
2
Number of patients with positive FVII inhibitor, anti- drug antibody (ADA)
✕. One or more tests are positive, such as HBsAg, HCV antibody, anti-human immunity for HIV antibody and anti-treponema pallidum specific antibody (TPHA);
✕. Except for hemophilia A or B, the coagulation indexes of any other bleeding disease or other diseases are obviously different(such as platelet disease, vitamin K deficiency, etc.);