CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 77 enrolled
Drug / intervention
IB1001 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00768287
NCT00768287Phase 3Completed
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Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Medexus Pharma, Inc.·interventional·Posted Oct 8, 2008·Updated Apr 6, 2021

In Brief

A Phase 3 clinical trial evaluating IB1001 and nonacog alfa for Hemophilia B. Completed, enrolled 77 participants across 23 sites in 7 countries.

Detailed Summary

Primary Objective: To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B. Key Secondary Objectives: To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesFrance, India, Israel, Italy, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2008
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2013
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.7 years ago

Interventions

IB1001biological

Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery

nonacog alfabiological

Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa