Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

ClinicalTrials.gov ID: NCT01736475

Public ClinicalTrials.gov record NCT01736475. 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.

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ClinicalTrials.gov public records Last synced Jul 23, 2026, 1:29 PM EDT

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Official title

A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A

Study identification

NCT ID: NCT01736475
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Baxalta now part of Shire; Industry
Enrollment: 159 participants

Conditions and interventions

Conditions

Hemophilia A

Interventions

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method Biological
PEGylated Recombinant Factor VIII Biological

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: Jan 30, 2013
Primary completion: Jul 16, 2014
Completion: Jul 16, 2014
Last update posted: May 19, 2021

2013 – 2014

United States locations

U.S. sites: 17
U.S. states: 14
U.S. cities: 17

Facility	City	State	ZIP	Site status
University of Colorado	Aurora	Colorado	80045	—
University of Florida, College of Medicine	Gainesville	Florida	32610	—
Children's Healthcare of Atlanta	Atlanta	Georgia	30322	—
Bleeding and Clotting Disorders Institute	Peoria	Illinois	61614	—
University of Kentucky Medical Center	Lexington	Kentucky	40504	—
University of Louisville Hospital	Louisville	Kentucky	40202	—
Tulane University Medical School	New Orleans	Louisiana	70124	—
Children's Mercy Hospitals & Clinics	Kansas City	Missouri	66211	—
Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York	10065	—
University of North Carolina Chapel Hill	Chapel Hill	North Carolina	27599	—
Duke University Medical Center	Durham	North Carolina	27710	—
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	—
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	—
Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	—
Palmetto Health	Columbia	South Carolina	29203	—
University of Utah Health Sciences Center	Salt Lake City	Utah	84132	—
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 55 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01736475, 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 19, 2021 · Synced Jul 23, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01736475 live on ClinicalTrials.gov.

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