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NCT01086852 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery
A Phase 3 study, sponsored by Bio Products Laboratory.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT01086852: Clinical Trial Phase 3 study, sponsored by Bio Products Laboratory.
NCT01086852 is a Phase 3 study that was terminated before completion, run by Bio Products Laboratory. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086852, a Phase 3 study, was terminated before completion, sponsored by Bio Products Laboratory.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery. The secondary efficacy endpoints are as follows: 1. A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery. 2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of post-operative bleeding, including location and duration. 3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion. 4. Assessment of FX:C and FX:Ag levels on each day post-surgery. 5. Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to maintain haemostasis. 6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis. 7. Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each post-operative day) to maintain haemostasis.
Primary Outcome
As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count. The clinical assessment was rated as follows: * Blood loss less than expected * Blood loss as expected * Blood loss more than expected * Blo
Interventions
- BIOLOGICAL FACTOR X
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Why NCT01086852 stopped before completion
NCT01086852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which FACTOR X is the first listed.
NCT01086852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086852 about?
NCT01086852 is a clinical study titled "Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery". To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery. The secondary efficacy endpoints are as follows: 1. A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery. 2. The incidence of ble...
What is the current status of trial NCT01086852?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2011-03. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01086852?
The interventions under investigation include: FACTOR X (BIOLOGICAL).
Who is sponsoring clinical trial NCT01086852?
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 NCT01086852's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 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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