{ "data": { "asOf": "2026-10-30T22:23:55.566Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT04046848", "title": "Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A", "scientificTitle": "Phase 1/2 Study to Assess the Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Previously Treated Adult Patients With Severe Hemophilia A", "status": "terminated", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "Severe Hemophilia A" ], "interventions": [ { "name": "OCTA101", "type": "DRUG", "description": "OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer)." } ], "sponsor": { "name": "Octapharma", "type": "INDUSTRY" }, "locations": [ { "city": "Sofia", "country": "Bulgaria", "facility": "Specialized Hospital for Active Treatment of Hematological Diseases EAD Clinic of Clinical Hematology" } ], "outcomes": { "other": [], "primary": [ "Patients Experiencing Adverse Events", "Participants Experiencing Dose-limiting Toxicities (DLTs)", "Patients Experiencing Thromboembolic Events", "Patients Experiencing Local Injection Site Reactions of Any Grade", "Inhibitor Formation to FVIII" ], "secondary": [ "Efficacy: Area Under the Concentration-time Curve (AUC) of FVIII:C", "Efficacy: Maximum Plasma Concentration (Cmax) of FVIII:C", "Efficacy: Time for Reaching Maximum Plasma Concentration (Tmax) of FVIII:C", "In Vivo Recovery (IVR) of FVIII:C", "Efficacy: Half-life (t1/2) of FVIII:C", "Efficacy: Mean Residence Time (MRT) of FVIII:C", "Efficacy: Area Under the Concentration-time Curve (AUC(0-tz)) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: Maximum Plasma Concentration (Cmax) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: Time for Reaching Maximum Plasma Concentration (Tmax) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: In Vivo Recovery (IVR) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: Half Life (t1/2) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: Mean Residence Time (MRT) of OCTA12 (a Recombinant Von Willebrand Factor Fragment Dimer)", "Efficacy: Total Annualized Bleeding Rate", "Efficacy: Spontaneous Annualized Bleeding Rate", "Efficacy: Total Annualized Treated Bleeding Rate", "Efficacy: Spontaneous Annualized Treated Bleeding Rate", "Efficacy: Traumatic Annualized Bleeding Rate", "Efficacy: Joint Annualized Bleeding Rate", "Efficacy: FVIII:C Trough and Peak Plasma Levels", "Efficacy: Efficacy of Treatment of Bleeding Episodes Using Score (4-point).", "Safety: Antibody Formation to OCTA12", "Safety: OCTA12 Plasma Levels", "Safety: Change in Hemoglobin", "Safety: Change in Alanine Aminotransferase (ALT)", "Safety: Change in Aspartate Transaminase (AST)", "Patients With Changes to Vital Signs", "Patients With Changes in Physical Examination Results" ] }, "eligibility": { "sex": "MALE", "criteria": "Inclusion Criteria:\n\n1. Severe hemophilia A (\\<1% FVIII:C) as documented in medical records\n2. Males ≥18 years of age\n3. Subjects who have had ≥150 exposure days (EDs) with a FVIII product\n4. Written informed consent for study participation obtained before undergoing any study specific procedures\n\nExclusion Criteria:\n\n1. Previous participation in this trial\n2. Use of an Investigational Medicinal Product within 30 days prior to the first OCTA101 injection\n3. History of FVIII inhibitors titre ≥0.6 BU/mL defined by medical records\n4. Inhibitors to FVIII (≥0.6 BU/mL) at screening measured by Nijmegen modified Bethesda method at central laboratory\n5. Human immunodeficiency virus (HIV) positive subjects with a CD4+ count \\<200/mL\n6. Clinically significant anemia at screening (hemoglobin \\<8 g/dL)\n7. 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\n8. Any coagulation disorder other than hemophilia A\n9. AST or ALT levels \\>3 times the upper limit of normal\n10. Creatinine \\>120 μmol/L\n11. Platelet count \\<100,000 μL\n12. BMI ≥30 kg/m²\n13. 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