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NCT04692181 · ClinicalTrials.gov registry record · Phase 1
SYN-004 Safety and Tolerability in Allo-HCT Subjects
A Phase 1 study of Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant and Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics, sponsored by Theriva Biologics.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04692181 is a Phase 1 study of Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant and Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics that is active but no longer recruiting, run by Theriva Biologics. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04692181, a Phase 1 study of Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant and Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics, is active but no longer recruiting, sponsored by Theriva Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP). 2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP. 3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP. 4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP
Conditions Studied
Interventions
- BIOLOGICAL SYN-004, Ribaxamase or Placebo
Study Locations (1)
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2030-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04692181
The ClinicalTrials.gov registry entry for NCT04692181 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theriva Biologics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant appearing as the primary indexed condition, and to 1 intervention - of which SYN-004, Ribaxamase or Placebo is the first listed.
NCT04692181 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04692181 about?
NCT04692181 is a clinical study titled "SYN-004 Safety and Tolerability in Allo-HCT Subjects". Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP). 2. To evaluate...
What is the current status of trial NCT04692181?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2021-02-15. Estimated completion is 2030-09-30.
What conditions does trial NCT04692181 study?
This clinical trial studies the following conditions: Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant, Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics.
What interventions are being tested in trial NCT04692181?
The interventions under investigation include: SYN-004, Ribaxamase or Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT04692181?
This trial is sponsored by Theriva Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04692181 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant
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Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
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Missouri
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