MedTrace Logo

Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

NCT01335061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-06-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.

Conditions

  • Hemophilia B

Interventions

BIOLOGICAL

Nonacog alfa

Period 1: During on-demand period, dosing at the discretion of investigator.

BIOLOGICAL

Nonacog alfa

Period 2: During the prophylaxis period, 100 IU/kg once weekly

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Bulgaria
  • Canada
  • Croatia
  • Malaysia
  • Mexico
  • Poland
  • Singapore
  • South Korea
  • Turkey (Türkiye)

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 NCT01335061 on ClinicalTrials.gov