Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01027377
First received: December 4, 2009
Last updated: September 12, 2013
Last verified: June 2011
  Purpose

The study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.


Condition Intervention Phase
Severe Hemophilia A
Drug: rFVIIIFc
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc. [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]
  • To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Cohort to receive a single low dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single low dose intravenous injection of rFVIIIFc with safety and PK assessments
Drug: rFVIIIFc
Single dose
Other Name: Recombinant Factor VIII fusion protein
Experimental: B
Cohort to receive a single high dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single high dose intravenous injection of rFVIIIFc with safety and PK assessments
Drug: rFVIIIFc
Single dose
Other Name: Recombinant Factor VIII fusion protein

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and 12 years of age and older and weigh at least 40 kg
  2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
  3. History of at least 100 exposure days to any Factor VIII product

Exclusion Criteria:

  1. History of Factor VIII inhibitors
  2. Kidney or liver dysfunction
  3. Diagnosed with another coagulation defect other than hemophilia A
  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: NCT01027377

Locations
United States, California
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
United States, Massachusetts
Biogen-Idec Hemophilia Unit
Waltham, Massachusetts, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United States, Washington
Research Site
Seattle, Washington, United States
Hong Kong
Research Site
Hong Kong, Hong Kong
Israel
Research Site
Tel Aviv, Israel
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec Hemophilia Unit
ClinicalTrials.gov Identifier: NCT01027377     History of Changes
Other Study ID Numbers: 998HA101
Study First Received: December 4, 2009
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

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 November 20, 2014