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NCT01029340 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
NCT01029340: Completed Phase 3 study, sponsored by Bayer.
NCT01029340 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 74 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01029340, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
Study Summary
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
Primary Outcome
To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.
Interventions
- BIOLOGICAL Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- BIOLOGICAL Recombinant Factor VIII (BAY81-8973)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01029340 record still lists
NCT01029340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Recombinant Factor VIII (Kogenate FS, BAY14-2222) is the first listed.
NCT01029340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01029340 about?
NCT01029340 is a clinical study titled "Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A". The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the am...
What is the current status of trial NCT01029340?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2009-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01029340?
The interventions under investigation include: Recombinant Factor VIII (Kogenate FS, BAY14-2222) (BIOLOGICAL), Recombinant Factor VIII (BAY81-8973) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01029340?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01029340's enrollment target sits among peer trials
74 1780th of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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