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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: Completed Phase 1 study of Hemophilia A, sponsored by Bayer.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00629837 record still lists
NCT00629837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 91-participant average among 42 other Hemophilia A trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00629837's enrollment target sits among peer trials
27 29th of 42 higher than 14 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A 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.
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