CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Kogenate (BAY14-2222)drug
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/NCT00586521
NCT00586521Phase 4Completed
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A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment

Bayer·interventional·Posted Jan 4, 2008·Updated Nov 3, 2014

In Brief

A Phase 4 clinical trial evaluating Kogenate (BAY14-2222) for Hematologic Disease and Hemophilia A. Completed, enrolled 20 participants across 11 sites in 5 countries.

Detailed Summary

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Disease, Hemophilia A
CountriesFrance, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.5 years ago

Interventions

Kogenate (BAY14-2222)drug

One group two treatment schedules, first on-demand then switch to prophylaxis