CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 159 enrolled
Drug / intervention
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method +3 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/NCT01736475
NCT01736475Phase 3Completed
CompareCT.gov

A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A

Baxalta now part of Shire·interventional·Posted Nov 29, 2012·Updated May 20, 2021

In Brief

A Phase 3 clinical trial evaluating Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method and PEGylated Recombinant Factor VIII for Hemophilia A. Completed, enrolled 159 participants across 72 sites in 20 countries.

Detailed Summary

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Austria, Bulgaria, Czechia, Germany, Israel, Japan, Lithuania, Malaysia, Netherlands, Poland, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2012
Enrollment StartJan 31, 2013
Primary CompletionJul 17, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.6 years ago

Interventions

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Methodbiological

Pharmacokinetic (PK) evaluation of ADVATE

PEGylated Recombinant Factor VIIIbiological

Pharmacokinetic (PK) evaluation of BAX 855

PEGylated Recombinant Factor VIIIbiological

Prophylaxis treatment

PEGylated Recombinant Factor VIIIbiological

On-demand treatment