CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS) +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/NCT01085344
NCT01085344Phase 4Completed

Moderate Term Musculoskeletal Outcomes With Escalating Dose Prophylaxis: the Canadian Hemophilia Prophylaxis Study Follow-up Study

The Hospital for Sick Children·interventional·Posted Mar 11, 2010·Updated Dec 5, 2019

In Brief

A Phase 4 clinical trial evaluating Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS) for Severe Hemophilia A. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Primary prophylaxis given less frequently initially, with the infusion frequency increased if needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with fewer complications than standard prophylaxis while reducing disability to a greater degree than intermittent therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2010
Enrollment StartJun 26, 1997
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 15.4 yearsPosted 16.3 years ago

Interventions

Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)biological

escalating dose prophylaxis

Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)biological

escalating dose