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Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

NCT00956345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-01-20

No results posted yet for this study

Summary

This trial is conducted in Europe, Japan and the United States of America (USA).

The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia B

Interventions

DRUG

nonacog beta pegol

Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)

DRUG

nonacog beta pegol

Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)

DRUG

nonacog beta pegol

Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Japan
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00956345 on ClinicalTrials.gov