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NCT06096116 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
A Phase 3 study of Acquired Antithrombin Deficiency, sponsored by Octapharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06096116: Recruiting Phase 3 study of Acquired Antithrombin Deficiency, sponsored by Octapharma.
NCT06096116 is a Phase 3 study of Acquired Antithrombin Deficiency that is actively recruiting participants, run by Octapharma. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096116, a Phase 3 study of Acquired Antithrombin Deficiency, is actively recruiting participants, sponsored by Octapharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Primary Outcome
The percentage of patients in each group in whom no further therapy containing antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and for maintaining it during CPB
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Human plasma derived antithrombin
Study Locations (20)
Other
- University Hospital Innsbruck - Innsbruck
- Vienna General Hospital AKH, Medical University of Vienna - Vienna
- Center of Cardiovascular and Transplant Surgery - Brno
- Institute for Clinical and Experimental Medicine - Prague
- CHU de Reims, Hôpital Robert Debré - Reims
- CHU de Rennes - Rennes
- Hospital of Lithuanian university of Health sciences Kauno Klinikos - Kaunas
- Institute for Cardiovascular Diseases C.C. Iliescu - Bucharest
North Carolina
- Duke University Medical Center - Durham
- Atrium Health Wake Forest Baptist - Winston-Salem
Ontario
- Kingston Health Sciences Centre - Kingston
- Toronto General Hospital - Toronto
California
- Stanford University School of Medicine - Stanford
Florida
- University of Miami - Miami
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- The Ohio State University - Columbus
Oklahoma
- OU Health University of Oklahoma Medical Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-08-21 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What NCT06096116 shows while recruiting
NCT06096116 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (84% lower).
The record links to 1 condition, with Acquired Antithrombin Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06096116 names 20 study sites across 11 states, led by Other, North Carolina, Ontario.
Frequently Asked Questions
What is clinical trial NCT06096116 about?
NCT06096116 is a clinical study titled "Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass". The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
What is the current status of trial NCT06096116?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2024-08-21. Estimated completion is 2028-03.
What conditions does trial NCT06096116 study?
This clinical trial studies the following conditions: Acquired Antithrombin Deficiency.
What interventions are being tested in trial NCT06096116?
The interventions under investigation include: Placebo (DRUG), Human plasma derived antithrombin (DRUG).
Who is sponsoring clinical trial NCT06096116?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096116 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06096116's enrollment target sits among peer trials
120 1620th of 2000 higher than 361 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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