Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB 029, in Pediatric PTP Subjects With Hemophilia B.

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Biogen Idec
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01440946
First received: September 16, 2011
Last updated: September 12, 2013
Last verified: April 2012
  Purpose

An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics (PK), and Efficacy of Recombinant Coagulation Factor IX Fc Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Previously-Treated Pediatric Subjects with Severe Hemophilia B.


Condition Intervention Phase
Hemophilia B
Drug: rFIXFc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kids BLONG - An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B.

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Frequency of Inhibitor Development [ Time Frame: 50 weeks +/- 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of annualised bleeding episodes [ Time Frame: 50 weeks +/- 7 days ] [ Designated as safety issue: No ]
  • Assessments of response to treatment with rFIXFc for bleeding episodes [ Time Frame: 50 weeks +/- 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylaxis
Prophylactic dose
Drug: rFIXFc
IV administration

Detailed Description:

Previously treated pediatric subjects will undergo an evaluation of the PK profile of pre-study FIX and rFIXFc, before starting prophylactic treatment with rFIXFc.

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe hemophilia B defined as ≤ 2iU/dL (≤2%)
  • < 12 years of age and weight ≥ 13kg.
  • History of at least 50 documented piror exposure days to FIX.
  • No history of development to FIX, or inhibitor

Exclusion Criteria:

  • Other coagulation disorders in addition to Hemophilia B
  • History of anaphylaxis associated with any FIX or IV immunoglobulin administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440946

Contacts
Contact: Hemophilia Clinical Trials A-BLONG-CCF-inbox@biogenidec.com

Locations
United States, Arizona
Research Site Recruiting
Phoenix, Arizona, United States
United States, California
Research Site Recruiting
Los Angeles, California, United States
Research Site Recruiting
Sacramento, California, United States
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States
United States, Hawaii
Research Site Recruiting
Honolulu, Hawaii, United States
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States
United States, Michigan
Research Site Recruiting
East Lansing, Michigan, United States
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States
Australia, Victoria
Research Site Recruiting
Melbourne, Victoria, Australia
Australia, Western Australia
Research Site Recruiting
West Perth, Western Australia, Australia
Hong Kong
Research Site Recruiting
Hong Kong, Hong Kong
Ireland
Research Site Recruiting
Dublin, Ireland
Netherlands
Research Site Recruiting
Utrecht, Netherlands
South Africa
Research Site Recruiting
Johannesburg, South Africa
United Kingdom
Research Site Recruiting
Basingstoke, United Kingdom
Research Site Recruiting
Cambridge, United Kingdom
Research Site Recruiting
London, United Kingdom
Sponsors and Collaborators
Biogen Idec
Swedish Orphan Biovitrum
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01440946     History of Changes
Other Study ID Numbers: 9HB02PED
Study First Received: September 16, 2011
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
rFIXFc
Pediatric B LONG

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on July 20, 2014