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A Study to Evaluate the Safety and Efficacy of VGB-R04 in Adult Hemophilia B Patients

NCT05441553 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-07-01

No results posted yet for this study

Summary

A multicenter, open, non-randomized, phase I/II, two-phase clinical study. The dose exploration phase was phase I, and the dose extension phase was phase II.

Conditions

  • Hemophilia B

Interventions

GENETIC

VGB-R04

A novel, bioengineered adeno-associated viral (AAV) vector carrying human factor IX variant

Sponsors & Collaborators

  • Shanghai Vitalgen BioPharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lei Zhang, PhD · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • China

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 NCT05441553 on ClinicalTrials.gov