Status:
TERMINATED
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
Lead Sponsor:
Octapharma
Conditions:
Severe Hemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-c...
Eligibility Criteria
Inclusion
- Severe hemophilia A (\<1% FVIII:C) as documented in medical records
- Males ≥18 years of age
- Subjects who have had ≥150 exposure days (EDs) with a FVIII product
- Written informed consent for study participation obtained before undergoing any study specific procedures
Exclusion
- Previous participation in this trial
- Use of an Investigational Medicinal Product within 30 days prior to the first OCTA101 injection
- History of FVIII inhibitors titre ≥0.6 BU/mL defined by medical records
- Inhibitors to FVIII (≥0.6 BU/mL) at screening measured by Nijmegen modified Bethesda method at central laboratory
- Human immunodeficiency virus (HIV) positive subjects with a CD4+ count \<200/mL
- Clinically significant anemia at screening (hemoglobin \<8 g/dL)
- Presence of any significant comorbidity (at the discretion of the investigator) that might confound the interpretation of the study data and/or that might put the patient at undue risk by participating in the trial
- Any coagulation disorder other than hemophilia A
- AST or ALT levels \>3 times the upper limit of normal
- Creatinine \>120 μmol/L
- Platelet count \<100,000 μL
- BMI ≥30 kg/m²
- For Cohort 6, patients with a positive LumiTope test at screening will be excluded
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04046848
Start Date
July 3 2019
End Date
February 18 2022
Last Update
February 13 2025
Active Locations (1)
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1
Specialized Hospital for Active Treatment of Hematological Diseases EAD Clinic of Clinical Hematology
Sofia, Bulgaria