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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: Completed Phase 1 study, sponsored by Janssen Scientific Affairs.
NCT02561923 is a Phase 1 study that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 158 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Volume of blood (BV) collected after a punch biopsy is performed.
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 |
What the finished NCT02561923 record still lists
NCT02561923 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT02561923 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02561923's enrollment target sits among peer trials
158 348th of 2000 higher than 1,650 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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