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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: Active 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.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Assess potential SYN-004 systemic absorption (if any) by measuring SYN-004 plasma concentrations
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 |
What the registry record for NCT04692181 still lists
NCT04692181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04692181's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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