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Completed Phase 3 Interventional Results available

BAX 855 PK-guided Dosing

ClinicalTrials.gov ID: NCT02585960

Public ClinicalTrials.gov record NCT02585960. 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, 9:55 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

Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A

Brief summary

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

1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

Study identification

NCT ID
NCT02585960
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
135 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Years to 65 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
Nov 23, 2015 (Actual)
Primary completion
Aug 5, 2018 (Actual)
Completion
Aug 5, 2018 (Actual)
Last update posted
May 25, 2021

2015 – 2018

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Phoenix Childrens Hospital Phoenix Arizona 85016-7710 —
Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center Tucson Arizona 85724 —
Children's Hospital Los Angeles Los Angeles California 90027 —
University of Colorado Aurora Colorado 80045 —
University of Florida College of Medicine Gainesville Florida 32610 —
Emory University-ECC Atlanta Georgia 30322 —
University of Kentucky Medical Center Lexington Kentucky 40504 —
University of Louisville KCPCRU Louisville Kentucky 40202 —
Tulane University New Orleans Louisiana 70112 —
Boston Children's Hospital Boston Massachusetts 02115 —
University of Nebraska Medical Center Omaha Nebraska 68198-5456 —
Gulf States Hemophilia Centre Houston Texas 77030 —
University of Utah 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 69 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02585960, 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 25, 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 NCT02585960 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →