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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027377
First Posted: December 7, 2009
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bioverativ Therapeutics Inc.
  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
Intervention Model: Crossover Assignment
Masking: None (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 Bioverativ Therapeutics Inc.:

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 ]

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 ]
  • To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate [ Time Frame: 78 weeks ]
  • To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc [ Time Frame: 78 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Bioverativ Therapeutics Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bioverativ Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01027377     History of Changes
Other Study ID Numbers: 998HA101
First Submitted: December 4, 2009
First Posted: December 7, 2009
Last Update Posted: February 28, 2017
Last Verified: February 2017

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


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