CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 303 enrolled
Drug / intervention
PLASMA DERIVED Factor VIII +1 moredrug
Likely dose
PLASMA DERIVED Factor VIII 50IUfrom 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/NCT01064284
NCT01064284Phase 4Completed
CompareCT.gov

Inhibitor Development in Previously Untreated Patients (PUPs) or Minimally Blood Component-Treated Patients (MBCTPs) When Exposed to Plasma-derived Von Willebrand Factor-Containing Factor VIII (VWF/FVIII) Concentrates and to Recombinant Factor VIII (rFVIII) Concentrates: An Independent, International, Multicentre, Prospective, Controlled, Randomised, Open Label, Clinical Trial

Fondazione Angelo Bianchi Bonomi·interventional·Posted Feb 8, 2010·Updated Aug 25, 2017

In Brief

A Phase 4 clinical trial evaluating PLASMA DERIVED Factor VIII and Recombinant FVIII for Hemophilia A. Completed, enrolled 303 participants across 48 sites in 14 countries.

Detailed Summary

The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII concentrates by determining the frequency of inhibitor development in previously untreated patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the first 3 years from enrollment, whichever occurs first. .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesArgentina, Austria, Brazil, Chile, Egypt, India, Iran, Italy, Mexico, Saudi Arabia, South Africa, Spain, Turkey (Türkiye), United States
CollaboratorsSintesi Research Srl

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.4 years ago

Interventions

PLASMA DERIVED Factor VIIIdrug

Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding

Recombinant FVIIIdrug

Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding