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Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B

NCT03855280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-05-16

Study results available
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Summary

Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects \< 12 years of age.

Conditions

  • Hemophilia B

Interventions

DRUG

APVO101

Subjects will receive a single IV dose of APVO101 twice weekly or at a frequency of infusions as determined appropriate by the investigator for the particular study subject for a total of 50 ED. The starting prophylaxis dose will be based on APVO101 recovery from PK Phase assessments (only pre-infusion and 15-30 minute post-infusion samples).

Sponsors & Collaborators

  • Medexus Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Khaled Mohamed · Medexus Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2022-07-04
Completion
2022-07-04
FDA Drug
Yes

Countries

  • Brazil
  • Georgia
  • Moldova
  • South Africa
  • Turkey (Türkiye)
  • Ukraine

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 NCT03855280 on ClinicalTrials.gov