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NCT02561923 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
A Phase 1 study, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
NCT02561923 is a Phase 1 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 158 participants.
The verdict
NCT02561923, a Phase 1 study, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin potential) changes induced by rivaroxaban at steady state, to better understand their potential role in bleeding reversal.
Interventions
- DRUG Saline
- DRUG Tranexamic acid
- DRUG Rivaroxaban
- DRUG Kcentra, a 4-factor PCC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2015-08-27 |
| Est. Completion | 2016-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02561923
The ClinicalTrials.gov registry entry for NCT02561923 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT02561923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02561923 about?
NCT02561923 is a clinical study titled "A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants". The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their effects on the antico...
What is the current status of trial NCT02561923?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2015-08-27. Estimated completion is 2016-06-17.
What interventions are being tested in trial NCT02561923?
The interventions under investigation include: Saline (DRUG), Tranexamic acid (DRUG), Rivaroxaban (DRUG), Kcentra, a 4-factor PCC (DRUG).
Who is sponsoring clinical trial NCT02561923?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
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