Study of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB 031, in Pediatric PTP Subjects With Hemophilia A

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01458106
First received: October 20, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

An Open-Label, Multi-Center, Evaluation of Safety Pharmacokinetic (PK) and Efficacy of Recombinant Coagulation Factor VIII Fc Protein, BIIB 031, in the Prevention and Treatment of Bleeding Episodes in Previously-Treated Pediatric Subjects with Severe Hemophilia A


Condition Intervention Phase
Hemophilia A
Drug: rFVIIIFc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kids ALONG - An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Frequency of inhibitor development [ Time Frame: 30 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of annualised bleeding episodes [ Time Frame: 26 Weeks +/- 7 days ] [ Designated as safety issue: Yes ]
  • Assessments of response to treatment with rFVIII Fc for bleeding episodes [ Time Frame: 26 Weeks +/- 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
prophylactic dose
Drug: rFVIIIFc
IV administration

Detailed Description:

Previously treated pediatric subjects will be treated with a prophylactic regimen of rFVIIIFc. PK analysis of pre-study FVIII and rFVIIIFc will be performed in a sub-group of the study subjects prior to commencement of prophylactic treatment for all subjects.

  Eligibility

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

Inclusion Criteria:

  • Severe hemophilia A defined as <1 IU/dL (<1%).
  • Male, <12 years of age and weight ≥13 kg.
  • History of at least 50 documented prior exposure days to FVIII
  • No current, or history of, inhibitor development to FVIII

Exclusion Criteria:

  • Other coagulation disorders in addition to Hemophilia A
  • History of anaphylaxis associated with any FVIII 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: NCT01458106

  Show 27 Study Locations
Sponsors and Collaborators
Biogen Idec
Swedish Orphan Biovitrum
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01458106     History of Changes
Other Study ID Numbers: 8HA02PED
Study First Received: October 20, 2011
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Hemophilia
Pediatric Subjects
FVIII
rFVIIIFc
Hemophilia A
Severe Hemophilia

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014