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NCT06072430 · ClinicalTrials.gov registry record · Phase 3
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
A Phase 3 study of Sepsis and Septic Shock, sponsored by Vivacelle Bio.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
- 6
- Study locations
NCT06072430: Recruiting Phase 3 study of Sepsis and Septic Shock, sponsored by Vivacelle Bio.
NCT06072430 is a Phase 3 study of Sepsis and Septic Shock that is actively recruiting participants, run by Vivacelle Bio. The registered enrollment target is 46 participants, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06072430, a Phase 3 study of Sepsis and Septic Shock, is actively recruiting participants, sponsored by Vivacelle Bio.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
Primary Outcome
The primary endpoint is defined as an elevation in average mean arterial pressure by at least 10 mmHg from baseline within 3 hours of initiation of study treatment on Day 1
Conditions Studied
Interventions
- DRUG VBI-S
Study Locations (6)
Arizona
- Dignity Health Chandler Regional Medical Center - Chandler
Georgia
- Memorial Health University Medical Center - Savannah
Missouri
- University Health - Kansas City
Nebraska
- Bryan Medical Center - Lincoln
North Carolina
- Novant Healthcare - Winston-Salem
Oregon
- Oregon Health & Science University (OHSU) - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What NCT06072430 shows while recruiting
NCT06072430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which VBI-S is the first listed.
NCT06072430 lists 6 locations in 6 states (Arizona, Georgia, Missouri).
Frequently Asked Questions
What is clinical trial NCT06072430 about?
NCT06072430 is a clinical study titled "A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)". This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
What is the current status of trial NCT06072430?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2024-08-06. Estimated completion is 2025-12.
What conditions does trial NCT06072430 study?
This clinical trial studies the following conditions: Sepsis, Septic Shock, Hypovolemia.
What interventions are being tested in trial NCT06072430?
The interventions under investigation include: VBI-S (DRUG).
Who is sponsoring clinical trial NCT06072430?
This trial is sponsored by Vivacelle Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072430 being conducted?
This trial has 6 study locations across Arizona, Georgia, Missouri, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06072430's enrollment target sits among peer trials
46 76th of 90 higher than 15 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis 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.
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