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Enzyme Inhibitor

SYN-004 for Post-Bone Marrow Transplant Complications

Phase 1 & 2
Recruiting
Research Sponsored by Synthetic Biologics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ≥18 years undergoing myeloablative allo-HCT for a hematologic malignancy or myeloproliferative disorder
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose of syn-004 or placebo, and up to 180 days after hct
Awards & highlights

Study Summary

This trial is testing a new drug, SYN-004, to see if it is safe and effective in treating patients who have had a bone marrow transplant and develop a fever.

Who is the study for?
Adults over 18 years old undergoing bone marrow transplant for blood disorders who can swallow a capsule and have consented to participate. They must not have severe kidney, heart, liver issues, lung function below 80%, certain infections or bleeding problems, be pregnant/breastfeeding, or allergic to the study drugs.Check my eligibility
What is being tested?
The trial is testing SYN-004's safety and its effects on gut bacteria in patients receiving bone marrow transplants who develop fevers treated with specific IV antibiotics. It also looks at how well SYN-004 enters the bloodstream and interacts with these antibiotics.See study design
What are the potential side effects?
Potential side effects are not detailed but would relate to the tolerability of oral SYN-004 capsules and any interactions it may have when taken alongside IV antibiotics like meropenem or piperacillin tazobactam.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and will have a stem cell transplant for blood cancer or disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours after iv administration of antibiotic
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours after iv administration of antibiotic for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bacteremia
Bacterial intestinal infections
Grade 3 or 4 adverse events
+3 more
Secondary outcome measures
First line failure of PIP/TAZO or FEP
Gut microbiome protection
Impact on immunosuppressant dosing
+1 more
Other outcome measures
GVHD and relapse free survival
Incidence of CDI
Bacteremia
+7 more

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: SYN-004 + IV MeropenemActive Control1 Intervention
SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Meropenem (MER)
Group II: SYN-004 + IV Piperacillin/TazobactamActive Control1 Intervention
SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Piperacillin/Tazobactam (PIP/TAZO)
Group III: SYN-004 + CefepimeActive Control1 Intervention
SYN-004, oral administration, 150mg, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Cefepime (FEP)
Group IV: Placebo + IV MeropenemPlacebo Group1 Intervention
Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Meropenem (MER)
Group V: Placebo + IV Piperacillin/TazobactamPlacebo Group1 Intervention
Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Piperacillin/Tazobactam (PIP/TAZO)
Group VI: Placebo + IV CefepimePlacebo Group1 Intervention
Placebo, oral administration, 4 times per day (q6h), beginning on day +1 after HCT until 72-hours after completion of IV Cefepime (FEP)

Find a Location

Who is running the clinical trial?

Synthetic Biologics Inc.Lead Sponsor
8 Previous Clinical Trials
679 Total Patients Enrolled
Theriva Biologics, Inc.Lead Sponsor
8 Previous Clinical Trials
679 Total Patients Enrolled
Washington University School of MedicineOTHER
1,928 Previous Clinical Trials
2,296,927 Total Patients Enrolled

Media Library

SYN-004 (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04692181 — Phase 1 & 2
Graft-versus-Host Disease Research Study Groups: Placebo + IV Meropenem, SYN-004 + IV Meropenem, Placebo + IV Piperacillin/Tazobactam, SYN-004 + IV Piperacillin/Tazobactam, Placebo + IV Cefepime, SYN-004 + Cefepime
Graft-versus-Host Disease Clinical Trial 2023: SYN-004 Highlights & Side Effects. Trial Name: NCT04692181 — Phase 1 & 2
SYN-004 (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04692181 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being signed up to try this new medical treatment?

"That is correct, the clinical trial detailed on clinicaltrials.gov is currently recruiting patients. The study was first posted on February 15th, 2021 and was last edited on April 19th, 2022. This particular trial needs to recruit 36 patients from 1 site."

Answered by AI

Are there any openings for patients who want to enroll in this clinical trial?

"Yes, this is an active trial that was first posted on February 15th, 2021 and updated April 19th, 2022. The study is enrolling 36 patients at 1 location."

Answered by AI

Why was this research project undertaken?

"The main metric which will be used to determine the success of this clinical trial is the Systemic antibiotic concentrations, which will be observed over the course of treatment and for a month after discontinuation. Additionally, researchers will also be measuring Gut microbiome protection (defined as changes from baseline in bacterial community composition, metabolic potential of gut bacteria, and antibiotic resistome), Impact on immunosuppressant dosing (defined as how SYN-004 affects immunosuppressant levels and dosage requirements), and Urine concentrations of 3-indoxyl sulfate (a biomarker for Clostridium and Enterococcus species) up to"

Answered by AI
~6 spots leftby Dec 2024