CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Laboratory Testsprocedure
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/NCT00950170
NCT00950170Phase 4Completed
CompareCT.gov

AN OPEN-LABEL STUDY OF THE SAFETY AND EFFICACY OF REFACTO AF IN PREVIOUSLY UNTREATED PATIENTS IN USUAL CARE SETTINGS

Pfizer·interventional·Posted Jul 31, 2009·Updated Jul 19, 2019

In Brief

A Phase 4 clinical trial evaluating Laboratory Tests for Hemophilia A. Completed, enrolled 23 participants across 11 sites in 7 countries.

Detailed Summary

Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesFrance, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 31, 2009
Enrollment StartFeb 10, 2010
Primary CompletionNov 24, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.9 years ago

Interventions

Laboratory Testsprocedure

Blood draws to determine the level of factor VIII activity before and after dosing at appropriate visits, and blood draws to determine levels of factor VIII inhibitor (antibody to factor VIII).