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A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

NCT06072430 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-04-04

No results posted yet for this 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.

Conditions

  • Septic Shock
  • Sepsis
  • Hypovolemia

Interventions

DRUG

VBI-S

VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

Sponsors & Collaborators

  • Vivacelle Bio

    lead INDUSTRY

Principal Investigators

  • Cuthbert O Simpkins, MD, FACS · Vivacelle Bio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06072430 on ClinicalTrials.gov