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NCT01736475 · ClinicalTrials.gov registry record · Phase 2
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT01736475 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 159 participants.
The verdict
NCT01736475, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
- BIOLOGICAL PEGylated Recombinant Factor VIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2014-07-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01736475
The ClinicalTrials.gov registry entry for NCT01736475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method is the first listed.
NCT01736475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01736475 about?
NCT01736475 is a clinical study titled "Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)". 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.
What is the current status of trial NCT01736475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2013-01-31. Estimated completion is 2014-07-17.
What interventions are being tested in trial NCT01736475?
The interventions under investigation include: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (BIOLOGICAL), PEGylated Recombinant Factor VIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT01736475?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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