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Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

NCT01233440 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-01-31

No results posted yet for this study

Summary

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

Recombinant Coagulation Factor IX Albumin Fusion Protein

Single dose of 25, 50 or 75 IU/kg of rIX-FP, given as intravenous infusion

BIOLOGICAL

Plasma derived FIX [pdFIX]

Single dose of 50 IU/kg of reference product, given as intravenous infusion

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Iris Jacobs, MD · CSL Behring

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Austria
  • France
  • Germany
  • Israel
  • Italy
  • 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 NCT01233440 on ClinicalTrials.gov