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Early Prophylaxis Immunologic Challenge (EPIC) Study

NCT01376700 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-05-24

Study results available
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Summary

The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.

Conditions

Interventions

BIOLOGICAL

Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)

Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.

Sponsors & Collaborators

  • Baxter Innovations GmbH

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-26
Primary Completion
2012-11-16
Completion
2012-11-16

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Spain

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 NCT01376700 on ClinicalTrials.gov