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Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients

NCT03186677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-11-10

Study results available
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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.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

BeneFIX

BeneFIX 75 IU/kg, intravenous administration

Sponsors & Collaborators

  • Catalyst Biosciences

    collaborator INDUSTRY

  • ISU Abxis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • ChurWoo You, PhD · Eulji University Hospital Seo-gu

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-03
Primary Completion
2018-10-10
Completion
2019-02-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186677 on ClinicalTrials.gov