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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 is a Phase 3 study of Acquired Antithrombin Deficiency that is actively recruiting participants, run by Octapharma. The registered enrollment target is 120 participants. The trial reports 20 study locations across 11 states.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096116
The ClinicalTrials.gov registry entry for NCT06096116 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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