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NCT00930176 · ClinicalTrials.gov registry record · Phase 3
A Study Investigating Treatment Factor X in People With Factor X Deficiency
A Phase 3 study, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT00930176: Completed Phase 3 study, sponsored by Bio Products Laboratory.
NCT00930176 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00930176, a Phase 3 study, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
Primary Outcome
Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg). Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Interventions
- BIOLOGICAL Human Coagulation FACTOR X
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00930176 record still lists
NCT00930176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Coagulation FACTOR X is the first listed.
NCT00930176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00930176 about?
NCT00930176 is a clinical study titled "A Study Investigating Treatment Factor X in People With Factor X Deficiency". The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
What is the current status of trial NCT00930176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2010-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00930176?
The interventions under investigation include: Human Coagulation FACTOR X (BIOLOGICAL).
Who is sponsoring clinical trial NCT00930176?
This trial is sponsored by Bio Products Laboratory, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00930176's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 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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