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NCT00629837 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980
A Phase 1 study of Hemophilia A, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT00629837 is a Phase 1 study of Hemophilia A that has completed, run by Bayer. The registered enrollment target is 27 participants, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00629837, a Phase 1 study of Hemophilia A, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.
Conditions Studied
Interventions
- BIOLOGICAL Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)
- BIOLOGICAL Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Locations (2)
California
- - Davis
- - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2005-09 |
| Est. Completion | 2006-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00629837
The ClinicalTrials.gov registry entry for NCT00629837 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (70% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions - of which Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980) is the first listed.
NCT00629837 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00629837 about?
NCT00629837 is a clinical study titled "Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980". The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) i...
What is the current status of trial NCT00629837?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2005-09. Estimated completion is 2006-03.
What conditions does trial NCT00629837 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT00629837?
The interventions under investigation include: Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980) (BIOLOGICAL), Recombinant Factor VIII (Kogenate FS, BAY14-2222) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00629837?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00629837 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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