CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg +1 morebiological
Likely dose
ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kgfrom 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.

Search/NCT03186677
NCT03186677Phase 1Completed
CompareCT.gov

A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients

ISU Abxis Co., Ltd.·interventional·Posted Jun 14, 2017·Updated Nov 10, 2020

In Brief

A Phase 1 clinical trial evaluating ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg and BeneFIX for Hemophilia B. Completed, enrolled 11 participants across 3 sites.

Detailed Summary

This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated hemophilia B patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesSouth Korea
CollaboratorsCatalyst Biosciences

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartJun 3, 2017
Primary CompletionOct 10, 2018
Study CompletionFeb 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.0 years ago

Interventions

ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kgbiological

ISU304/CB2679d/Dalcinonacog alfa 75\~150 IU/kg by intravenous or subcutaneous

BeneFIXbiological

BeneFIX 75 IU/kg, intravenous administration