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Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B

NCT03995784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-09

Study results available
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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.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

Coagulation Factor IX variant

Single intravenous injection of CB2679d/Dalcinonacog alfa

BIOLOGICAL

Coagulation Factor IX variant

Daily subcutaneous injections of CB2679d/Dalcinonacog alfa for 28 days

Sponsors & Collaborators

  • Catalyst Biosciences

    lead INDUSTRY

Principal Investigators

  • Howard Levy, MD, PhD, MMM · Catalyst Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2020-02-28
Completion
2020-04-30

Countries

  • South Africa

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 NCT03995784 on ClinicalTrials.gov