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NCT00618098 · ClinicalTrials.gov registry record · Phase 3
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
A Phase 3 study of Reversal of Anticoagulant Treatment, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT00618098: Completed Phase 3 study of Reversal of Anticoagulant Treatment, sponsored by Octapharma.
NCT00618098 is a Phase 3 study of Reversal of Anticoagulant Treatment that has completed, run by Octapharma. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00618098, a Phase 3 study of Reversal of Anticoagulant Treatment, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
Primary Outcome
Number of patients who had an INR response, defined as the correction of patient's INR to \<1.5, 15 minutes after the end of first infusion with study medication
Conditions Studied
Interventions
- BIOLOGICAL Octaplex (human prothrombin complex concentrate)
- BIOLOGICAL Fresh frozen plasma
Study Locations (1)
Pennsylvania
- Contact Octapharma for Facility details - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT00618098 record still lists
NCT00618098 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Reversal of Anticoagulant Treatment appearing as the primary indexed condition, and to 2 interventions - of which Octaplex (human prothrombin complex concentrate) is the first listed.
NCT00618098 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00618098 about?
NCT00618098 is a clinical study titled "Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures". The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
What is the current status of trial NCT00618098?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2008-05. Estimated completion is 2012-08.
What conditions does trial NCT00618098 study?
This clinical trial studies the following conditions: Reversal of Anticoagulant Treatment.
What interventions are being tested in trial NCT00618098?
The interventions under investigation include: Octaplex (human prothrombin complex concentrate) (BIOLOGICAL), Fresh frozen plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT00618098?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00618098 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618098's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 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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