Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
Completed · Phase 2/Phase 3
Conditions studied: Hemophilia A
In brief
To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.
Key facts
- Study ID
- NCT01736475
- Run by
- Baxalta now part of Shire
- People needed
- 159
- Starts
- 2013-01-31
- Expected to finish
- 2014-07-17
- Last updated by the study team
- 2021-05-20
Who can join
Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
Where it is running
- University of Florida, College of Medicine — Gainesville, Florida, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States
- University of Kentucky Medical Center — Lexington, Kentucky, United States
- University of Louisville Hospital — Louisville, Kentucky, United States
- Tulane University Medical School — New Orleans, Louisiana, United States
- Children's Mercy Hospitals & Clinics — Kansas City, Missouri, United States
- Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States
- University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- Palmetto Health — Columbia, South Carolina, United States
- University of Utah Health Sciences Center — Salt Lake City, Utah, United States
- Puget Sound Blood Group — Seattle, Washington, United States
- Royal Adelaide Hospital — Adelaide, South Australia, Australia
- The Alfred Hospital — Clayton, Victoria, Australia
- Fremantle Hospital — Fremantle, Western Australia, Australia
- Hollywood Specialist Centre — Nedlands, Western Australia, Australia
- Landes-Frauen-und Kinderklinik Linz — Linz, Austria
- AKH - Medizinische Universität Wien — Vienna, Austria
- SHAT of Oncohaematology Diseases — Sofia, Bulgaria
- Fakultni nemocnice Brno — Brno, Czechia
- University of Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.