At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
Coagulation Factor IX variant +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2b Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Subcutaneous Prophylaxis Treatment Regimen of CB2679d, in Adult Subjects With Hemophilia B
In Brief
A Phase 2 clinical trial evaluating Coagulation Factor IX variant for Hemophilia B. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesSouth Africa
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartJun 2019
First PostedJun 2019
Primary CompletionFeb 2020
Study CompletionApr 2020
TodayJul 2026
First PostedJun 24, 2019
Enrollment StartJun 18, 2019
Primary CompletionFeb 28, 2020
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.0 years ago
Interventions
Coagulation Factor IX variantbiological
Single intravenous injection of CB2679d/Dalcinonacog alfa
Coagulation Factor IX variantbiological
Daily subcutaneous injections of CB2679d/Dalcinonacog alfa for 28 days