Viewing Study NCT00093210



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00093210
Status: COMPLETED
Last Update Posted: 2007-12-05
First Post: 2004-10-04

Brief Title: Study Evaluating of Recombinant Human Factor IX BeneFIX and a New Formulation of BeneFIX rFIX-R in Moderate to Severe Hemophilia B
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Organization: Wyeth is now a wholly owned subsidiary of Pfizer

Study Overview

Official Title: A Double-Blind Randomized Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX BeneFIX and a New Formulation of BeneFIX rFIX-R and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe FIXC2 Hemophilia B
Status: COMPLETED
Status Verified Date: 2007-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments rFIX and rFIX-R when given as a 10-minute intravenous bolus infusion
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None