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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: Completed Phase 2 study, sponsored by Baxalta now part of Shire.
NCT01736475 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.
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 |
What the finished NCT01736475 record still lists
NCT01736475 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method is the first listed.
NCT01736475 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01736475's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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