Brief Title
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B
Official Title
Efficacy and Safety of Factor IX (FIX) Contained in AlphaNine® and Its Pharmacokinetic Comparison With BeneFIX® in Patients With Severe Hereditary Haemophilia B
Brief Summary
The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.
Detailed Description
Two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. The first pharmacokinetic study (PK1) was performed after a single dose of AlphaNine. The second pharmacokinetic study (PK2) was performed following 26 Weeks of AlphaNine treatment after PK1. To compare AlphaNine with BeneFIX, a third pharmacokinetic study (PK3) (current study) was performed after a single dose of BeneFIX administered following a 7- to 15-day wash-out period. The main objective of the PK3 study was to assess the pharmacokinetic profile of BeneFIX and compare to the pharmacokinetic profile of AlphaNine from the PK2 study.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Mean Difference of Area Under the Curve (AUC): BeneFIX Compared to AlphaNine
Condition
Hemophilia B
Intervention
BeneFIX
Study Arms / Comparison Groups
BeneFIX
Description: BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
13
Start Date
August 2005
Completion Date
October 2009
Primary Completion Date
October 2009
Eligibility Criteria
Key Inclusion Criteria: - Participated in the previous study "Efficacy and safety of factor IX (FIX) contained in Alphananine in patients with severe hereditary haemophilia B": - Congenital deficiency in Factor IX (FIX) - FIX residual activity of ≤2% of normal - Had required FIX-containing products in the past and in clinical records that were collected data to assess a reliable estimation of at least 150 treatment exposure days to previous products - Was able to receive treatment for more than 10 days for a 6-month period Key Exclusion Criteria: - Received a dose of FIX in the 7 days prior to the infusion - FIX inhibitor level of >0.5 Bethesda units (BU) or clinically relevant presence in the past (≥5 BU) - Active bleeding at the moment of infusion - Had a known allergic reaction to any BeneFIX component - Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the time of the first infusion - Had any disease that might affect the distribution or metabolism of FIX and which could affect interpretation of the study (such as non-controlled diabetes mellitus) - Had non-controlled arterial hypertension - Had abnormal renal function (creatinine >1.5 mg/dL) - Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (ALT) levels 2.5x upper limit of normal (ULN ) - Prevision to be concomitantly treated with other FIX-containing products - Had conditions that might affect subject compliance (survival-limiting [in 2 year time] diseases, alcohol or other drug abuse, etc.) - Unable to provide a storage plasma sample before the first dose of BeneFIX
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT03091751
Organization ID
IG-404-1
Responsible Party
Sponsor
Study Sponsor
Grifols Biologicals, LLC
Study Sponsor
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Verification Date
June 2017