Trial record 2 of 5 for:    rFVIIIFc

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01181128
First received: August 12, 2010
Last updated: September 12, 2013
Last verified: November 2012
  Purpose

The study is to investigate safety, pharmacokinetics (the determination of the concentration of drug in blood over time) and efficacy 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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ALONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total annualized rFVIIIFc consumption per subject [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of PK parameter estimates of rFVIIIFc and rFVIII [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of subject's response to treatment [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of rFVIIIFc used in a surgical subgroup [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Individualized Prophylaxis
Drug: rFVIIIFc
IV administration
Experimental: B
Weekly Prophylaxis
Drug: rFVIIIFc
IV administration
Experimental: C
Episodic (on demand) treatment
Drug: rFVIIIFc
IV administration

Detailed Description:

The current hemophilia standard of care for the prevention of bleeds and arthropathy is to maintain FVIII activity level above 1%. Due to the short half-life of the current FVIII products, prophylaxis therapy will require injection of 2-3 times per week or every other day. Treatment usually involves intravenous access, an invasive procedure, especially difficult in children. Episodic treatment will involve 1-3 injections to treat bleeding episodes, depending on the severity of the hemorrhage. Severe hemophilia patients will treat prophylactically with the long-lasting recombinant factor VIII Fc fusion protein (rFVIIIFc) in an interval to maintain FVIII activity level above 1%. Any bleeding episodes will be reported. The response to treatment will also be recorded to access the effectiveness of the rFVIIIFc.

  Eligibility

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

Inclusion Criteria:

  • Male, ≥12 years of age and weigh at least 40 kg
  • Diagnosed with severe hemophilia A defined as <1 IU/dL (<1%) endogenous Factor VIII)
  • History of at least 150 documented prior exposure days to any Factor VIII product
  • Platelet count ≥100,000 cells/μL

Exclusion Criteria:

  • History of Factor VIII inhibitors
  • Kidney and liver dysfunction
  • Diagnosed with other coagulation disorder(s) other than hemophilia A
  • Prior history of hypersensitivity or 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: NCT01181128

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Locations
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
United States, District of Columbia
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Washington, District of Columbia, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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East Lansing, Michigan, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
United States, Utah
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Salt Lake City, Utah, United States
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Seattle, Washington, United States
Australia, New South Wales
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Camperdown, New South Wales, Australia
Australia, Queensland
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Herston, Queensland, Australia
Australia, South Australia
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Adelaide, South Australia, Australia
Australia, Western Australia
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Perth, Western Australia, Australia
Austria
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Wien, Austria, 1090
Belgium
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Bruxelles, Belgium, 1200
Brazil
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Campinas, Brazil
Canada
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Calgary, Canada, T2N 2T9
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Toronto, Canada
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Vancouver, Canada, V6Z 1Y6
France
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Lyon Cedex 3, France, 69437
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Marseille, France, 13005
Germany
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Berlin, BE, Germany
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Bonn, NW, Germany
Hong Kong
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Hong Kong, Hong Kong
India
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New Delhi, Delhi, India
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Bangalore, Karna, India
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Pune, Mahara, India
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Ludhiana, Punjab, India
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Vellore, Tamilnadu, India
Israel
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Ramat Gan, Israel, 52621
Italy
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Firenze, FI, Italy
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Milano, MI, Italy
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Vicenza, VI, Italy
Japan
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Kashihara-shi, Japan
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Kawasaki-shi, Japan
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Kitakyushu-shi, Japan
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Nagoya-shi, Japan
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Shinjuku-ku, Japan
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Suginami-ku, Japan
New Zealand
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Auckland, New Zealand, 1023
Research Site
Christchurch, New Zealand, 8001
Research Site
Palmerston North, New Zealand, 4442
Poland
Research Site
Gdansk, Poland, 80-952
South Africa
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Johannesburg Parktown, Gauteng, South Africa
Research Site
Cape Town, W Cape, South Africa
Spain
Research Site
Barcelona, Spain
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Madrid, Spain
Sweden
Research Site
Göteborg, Sweden, 41345
Research Site
Malmö, Sweden, 20502
Research Site
Stockholm, Sweden, 17176
Switzerland
Research Site
Zuerich, Switzerland
United Kingdom
Research Site
Basingstoke, United Kingdom, RG24 9NA
Research Site
Cambridge, United Kingdom, CB2 2QQ
Research Site
Glasgow, United Kingdom, G4 0SF
Research Site
London, United Kingdom, NW3 2QG
Research Site
London, United Kingdom, SE1 7EH
Research Site
Oxford, United Kingdom, OX3 7LJ
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
ClinicalTrials.gov Identifier: NCT01181128     History of Changes
Other Study ID Numbers: 997HA301
Study First Received: August 12, 2010
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014