Phase 2
N=6
Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B
Hemophilia B
Bottom Line
View on ClinicalTrials.gov: NCT03995784 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Subjects Who Achieved FIX Level ≥12% — 3; 4; 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Coagulation Factor IX variant (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Catalyst Biosciences
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Achieved FIX Level ≥12% |
3; 4; 4; 4; 5 | — |
| SECONDARY FIX Activity Levels (Actual and Change From Baseline) in All Subjects |
0.24; 11.54; 25.538; 25.238; 15.05; 14.75 | — |
| SECONDARY Pharmacokinetic (PK) Analysis - AUC |
126.0306; 75.415 | — |
| SECONDARY PK Analysis - Clearance |
0.8191544 | — |
| SECONDARY PK Analysis - Maximum Concentration During SC Dosing |
20.74 | — |
| SECONDARY PK Analysis - Half-Life and Residence Time |
5.32395; 3.87172; 6.1572 | — |
| SECONDARY PK Analysis - Volume of Distribution at Steady-State Observed |
5.00736 | — |
| SECONDARY Occurrence of Clinical Thrombotic Event |
— | — |
| SECONDARY Occurrence of an Antibody Response |
2; 0 | — |
| SECONDARY Thrombogenicity Assessment - Fibrinogen |
300.4; 305.6; 326.4; 20.8; 296.2; -9.4 | — |
| SECONDARY Thrombogenicity Assessment - D-Dimer |
169.6; 218.6; 209.6; -9.0; 654.6; 436.0 | — |
| SECONDARY Thrombogenicity Assessment - Prothrombin Fragments 1 + 2 |
151.2; 187.8; 195.2; 7.4; 171.4; -16.4 | — |
| SECONDARY Thrombogenicity Assessment - Thrombin/Antithrombin |
9.34; 1.93; 4.42; 2.14; 3.86; 1.58 | — |
Summary
Phase 2b, single-center, open-label study designed to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneous (SC) prophylaxis treatment regimens with CB2679d in 6 adult, male subjects with severe congenital hemophilia B.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of severe ( A.
- Significant contraindication to participation.
Data sourced from ClinicalTrials.gov (NCT03995784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.