Clinical Trial: Phase I/IIa Study of FIXFc in Hemophilia B Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/IIa Safety and Pharmacokinetic Study of Intravenous FIXFc in Previously Treated Hemophilia B Patients
Brief Summary: The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
Detailed Summary: This study was previously posted by Syntonix Pharmaceuticals, Inc. In January, 2007, sponsorship of the trial was transferred to Biogen Idec.
Sponsor: Bioverativ Therapeutics Inc.
Current Primary Outcome: Number of Participants experiencing Adverse Events [ Time Frame: Up to 45 days ]
Original Primary Outcome: • Safety of a single-dose of intravenous FIXFc. Safety will be evaluated by adverse events and laboratory changes over time. [ Time Frame: 45 days ]
Current Secondary Outcome:
- Time to reach maximum concentration (Tmax) [ Time Frame: Up to 45 days ]
- Maximum concentration (Cmax) [ Time Frame: Up to 45 days ]
- Half-life (t½) [ Time Frame: Up to 45 days ]
- Clearance (CL) [ Time Frame: Up to 45 days ]
- Volume of distribution (Vd) [ Time Frame: Up to 45 days ]
- Area under the curve (AUC) [ Time Frame: Up to 45 days ]
- Mean residence time (MRT) [ Time Frame: Up to 45 days ]
- Incremental recovery (K) [ Time Frame: Up to 45 days ]
- Factor IX protein (FIX) activity [ Time Frame: Up to 45 days ]
- Recombinant (FIXFc) concentration over time curves [ Time Frame: up to 45 days ]
Original Secondary Outcome: • The study will estimate the pharmacokinetic parameters of a long-acting FIX following a single intravenous dose. [ Time Frame: 45 days ]
Information By: Bioverativ Therapeutics Inc.
Dates:
Date Received: July 14, 2008
Date Started: April 2008
Date Completion:
Last Updated: February 27, 2017
Last Verified: February 2017
