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Completed Phase 3 Interventional Results available

BAX 855 Continuation

ClinicalTrials.gov ID: NCT01945593

Public ClinicalTrials.gov record NCT01945593. 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 29, 2026, 6:28 AM 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 Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A

Brief summary

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

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

Study identification

NCT ID
NCT01945593
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
218 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
Up to 75 Years
Sex
All
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
Oct 15, 2013 (Actual)
Primary completion
Mar 2, 2018 (Actual)
Completion
Mar 2, 2018 (Actual)
Last update posted
May 24, 2021

2013 – 2018

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
Phoenix Childrens Hospital Phoenix Arizona 85016-7710 —
University of Colorado Aurora Colorado 80045 —
University of Florida College of Medicine Gainesville Florida 32610-0278 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611-2605 —
Bleeding and Clotting Disorders Institute Peoria Illinois 61614 —
University of Kentucky Medical Center Lexington Kentucky 40536-0284 —
University of Louisville Louisville Kentucky 40202 —
Tulane University School of Medicine New Orleans Louisiana 70112 —
Children's Mercy Hospitals & Clinics Kansas City Missouri 64108 —
North Shore-Long Island Jewish Health System New Hyde Park New York 11040 —
New York - Presbyterian/Weill Cornell Medical Center New York New York 10065 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599-7016 —
Duke University Medical Center Durham North Carolina 27705 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Nationwide Children's Hospital Columbus Ohio 43205 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
Penn State Hershey Cancer Center Hershey Pennsylvania 17033 —
Palmetto Health Richland Columbia South Carolina 29203-6863 —
University of Utah Salt Lake City Utah 84108 —
Puget Sound Blood Group 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 68 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01945593, 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 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01945593 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →