CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
PEGylated Recombinant Factor VIII +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/NCT02615691
NCT02615691Phase 3Completed
CompareCT.gov

Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

Baxalta now part of Shire·interventional·Posted Nov 26, 2015·Updated Jul 28, 2025

In Brief

A Phase 3 clinical trial evaluating PEGylated Recombinant Factor VIII and ITI for Hemophilia A. Completed, enrolled 120 participants across 91 sites in 23 countries.

Detailed Summary

This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustria, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Norway, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 26, 2015
Enrollment StartNov 12, 2015
Primary CompletionOct 29, 2024
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 10.6 years ago

Interventions

PEGylated Recombinant Factor VIIIbiological

Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII).

ITIbiological

Immune tolerance induction therapy