Trials / Completed
CompletedNCT01736475
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method | Pharmacokinetic (PK) evaluation of ADVATE |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Pharmacokinetic (PK) evaluation of BAX 855 |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | Prophylaxis treatment |
| BIOLOGICAL | PEGylated Recombinant Factor VIII | On-demand treatment |
Timeline
- Start date
- 2013-01-31
- Primary completion
- 2014-07-17
- Completion
- 2014-07-17
- First posted
- 2012-11-29
- Last updated
- 2021-05-20
- Results posted
- 2016-09-07
Locations
72 sites across 20 countries: United States, Australia, Austria, Bulgaria, Czechia, Germany, Israel, Japan, Lithuania, Malaysia, Netherlands, Poland, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01736475. Inclusion in this directory is not an endorsement.