CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FSdrug
Likely dose
Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS 250 unitsfrom 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/NCT00717626
NCT00717626Phase 2Completed
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Pilot Study of Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A

The Hospital for Sick Children·interventional·Posted Jul 17, 2008·Updated Oct 8, 2020

In Brief

A Phase 2 clinical trial evaluating Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS for Hemophilia A. Completed, enrolled 14 participants across 3 sites.

Detailed Summary

The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization of once-daily prophylaxis to allow us to set a sample size for a definitive trial.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartJul 1, 2008
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.0 years ago

Interventions

Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FSdrug

Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is \< 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.