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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 74 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01029340
The ClinicalTrials.gov registry entry for NCT01029340 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Recombinant Factor VIII (Kogenate FS, BAY14-2222) is the first listed.
NCT01029340 reports 0 study locations.
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.
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