Trial record 1 of 7 for:    rFVIIIFc
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Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A (ASPIRE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01454739
First received: September 29, 2011
Last updated: January 29, 2015
Last verified: November 2014
  Purpose

The primary objective of the study is to evaluate the long-term safety of rFVIIIFc in subjects with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in subjects with hemophilia A.


Condition Intervention Phase
Hemophilia A
Drug: BIIB031 (rFVIIIFc)
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: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated 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: Up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The annualized number of bleeding episodes (spontaneous and traumatic) per subject [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • The annualized number of spontaneous joint bleeding episodes per subject [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • The total number of days of exposure per subject per year [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • The consumption of rFVIIIFc as total dose per kg per subject per year [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Physician's global assessment of response to treatment using a 4-point scale [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Subject's assessment of response to treatment using a 4-point scale [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • The incidence of Averse Events and serious adverse events (SAEs) [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
  • Investigator/Surgeon assessment of hemostatic response to surgery using the 4-point bleeding response scale [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Number of injections and dose per injection to maintain hemostasis during the surgical period [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Estimated blood loss (mL) during surgery and post-operative period [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Number of blood product units transfused during surgery [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: December 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: On-Demand
The individual dose of rFVIIIc to treat bleeding episodes will be based on subject's clinical condition, type and severity of the bleeding event, and if indicated, FVIII levels.
Drug: BIIB031 (rFVIIIFc)
IV administration
Other Names:
  • ELOCTATE
  • rFVIIIFc
Experimental: B: Prophylaxis
Tailored prophylaxis, weekly prophylaxis or personalized prophylaxis available.
Drug: BIIB031 (rFVIIIFc)
IV administration
Other Names:
  • ELOCTATE
  • rFVIIIFc

Detailed Description:

Participant will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies (A-LONG - 997HA301 (NCT01181128), pediatric study 8HA02PED (NCT01458106) and 997HA307 (NCT02083965).

.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965 and NCT01458106)
  • Ability to understand purposes and risks of the study and to provide signed and dated informed consent

Key Exclusion Criteria:

  • Confirmed positive high-titer inhibitor test

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  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: NCT01454739

  Show 74 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01454739     History of Changes
Other Study ID Numbers: 8HA01EXT, 2011-003072-37
Study First Received: September 29, 2011
Last Updated: January 29, 2015
Health Authority: Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Ministry of Health
Hong Kong: Department of Health
Italy: Ministry of Health
South Africa: Department of Health
Austria: Agency for Health and Food Safety
New Zealand: Medsafe
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Brazil: Ministry of Health
Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Keywords provided by Biogen Idec:
rFVIIIFc
A-LONG Extension

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

ClinicalTrials.gov processed this record on May 21, 2015