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Terminated Phase 3 Interventional Results available

Early Prophylaxis Immunologic Challenge (EPIC) Study

ClinicalTrials.gov ID: NCT01376700

Public ClinicalTrials.gov record NCT01376700. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 6:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3b Clinical Study to Assess Whether Regular Administration of ADVATE in the Absence of Immunological Danger Signals Reduces the Incidence Rate of Inhibitors in Previously Untreated Patients With Hemophilia A

Study identification

NCT ID
NCT01376700
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
22 participants

Conditions and interventions

Conditions

Interventions

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

Biological

Eligibility (public fields only)

Age range
Up to 1 Year
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 25, 2011
Primary completion
Nov 15, 2012
Completion
Nov 15, 2012
Last update posted
May 23, 2021

2011 – 2012

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Not listed Indianapolis Indiana
Not listed New Brunswick New Jersey

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01376700, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 23, 2021 · Synced Jul 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01376700 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →