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Completed Phase 3 Interventional Results available

Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

ClinicalTrials.gov ID: NCT01029340

Public ClinicalTrials.gov record NCT01029340. 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 Jun 25, 2026, 5:07 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 Two Part Randomized Cross-Over Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety Profile of Plasma Protein-Free Recombinant FVIII Formulated With Sucrose (BAY81-8973) in Previously Treated Subjects With Severe Hemophilia A Under Prophylaxis Therapy

Study identification

NCT ID
NCT01029340
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
74 participants

Conditions and interventions

Interventions

  • Recombinant Factor VIII (BAY81-8973) Biological
  • Recombinant Factor VIII (Kogenate FS, BAY14-2222) 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
Nov 30, 2009
Primary completion
May 31, 2012
Completion
Feb 28, 2013
Last update posted
Nov 27, 2016

2009 – 2013

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Not listed Orange California 92868
Not listed Sacramento California 95817
Not listed Tampa Florida 33607
Not listed Boston Massachusetts 02115
Not listed East Lansing Michigan 48823
Not listed Kansas City Missouri 64108-9898
Not listed Cleveland Ohio 44106-2602

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 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01029340, 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 Nov 27, 2016 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01029340 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →