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Completed Phase 3 Interventional Results available

Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures

ClinicalTrials.gov ID: NCT01913405

Public ClinicalTrials.gov record NCT01913405. 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 Oct 21, 2026, 2:39 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 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.

Study identification

NCT ID
NCT01913405
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
30 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Years to 65 Years
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
Dec 20, 2013 (Actual)
Primary completion
Sep 23, 2016 (Actual)
Completion
Sep 23, 2016 (Actual)
Last update posted
May 24, 2021

2013 – 2016

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
University of Florida College of Medicine Gainesville Florida 32610 —
Bleeding and Clotting Disorders Institute Peoria Illinois 61614 —
University of Louisville Louisville Kentucky 40202 —
Children's Mercy Hospitals & Clinics Kansas City Missouri 64108 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
University of Utah Health Sciences Center Salt Lake City Utah 84132 —
University of Washington Seattle Washington 98104 —

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 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01913405, 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 24, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01913405 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →