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A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B

NCT01662531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-05-09

Study results available
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Summary

This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

rIX-FP

Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Russia
  • Spain

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 NCT01662531 on ClinicalTrials.gov