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Survey of Inhibitors in Plasma-Product Exposed Toddlers

NCT01064284 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2017-08-25

Study results available
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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.

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Conditions

Interventions

DRUG

PLASMA DERIVED Factor VIII

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

DRUG

Recombinant FVIII

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

Sponsors & Collaborators

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Fondazione Angelo Bianchi Bonomi

    lead OTHER

Principal Investigators

  • Pier M. Mannucci, Professor · Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano

  • Flora Peyvandi, Professor · Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Chile
  • Egypt
  • India
  • Iran
  • Italy
  • Mexico
  • Saudi Arabia
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064284 on ClinicalTrials.gov