Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B (B-YOND)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Biogen Idec

ClinicalTrials.gov Identifier:

NCT01425723

First received: August 19, 2011

Last updated: May 15, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 19, 2011
Last Updated Date	May 15, 2013
Start Date ^ICMJE	December 2011
Estimated Primary Completion Date	December 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 29, 2011)	Frequency of inhibitor development [ Time Frame: up to four years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01425723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 15, 2013)	The number of annualized bleeding episodes (spontaneous and traumatic) per subject [ Time Frame: up to 4 years ] [ Designated as safety issue: No ] The number of annualized 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 mean dose of rFIXFc per kg per subject per year per treatment regimen [ Time Frame: up to 4 years ] [ Designated as safety issue: No ] Physicians global assessment of response to traetment 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 AEs 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 hemostatis 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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 29, 2011)	number of bleeding episodes per subject [ Time Frame: up to four years ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
Official Title ^ICMJE	An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
Brief Summary	The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophillia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
Detailed Description	Subjects 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, B-LONG 998HB102 (NCT01027364) and pediatric study 9HB02PED (NCT01440946)
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Severe Hemophilia B
Intervention ^ICMJE	Biological: rFIXFc IV Administration
Study Arm (s)	Experimental: A On-Demand Intervention: Biological: rFIXFc Experimental: B Prophylaxis Intervention: Biological: rFIXFc
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	December 2015
Estimated Primary Completion Date	December 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects who have completed previous rFIXFc studies (NCT01027364 and NCT01440946) Ability to understand the purposes & risks of the study and provide signed and dated informed consent. Exclusion Criteria: Confirmed positive high-titer inhibitor test -
Gender	Male
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Belgium, Brazil, France, Germany, Hong Kong, India, Italy, Japan, Poland, South Africa, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01425723
Other Study ID Numbers ^ICMJE	9HB01EXT, 2011-003075-11
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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