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Vancomycin Pre-Treatment

Phase 1

Allogeneic Hematopoietic Stem Cell Transplantation | Small molecule | Hematology |Seres Therapeutics, Inc.|Last Updated: Oct 1, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Vancomycin Pre-Treatment · 1 trial · 1 indication

Phase 1 1
NCT04995653A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCTAllogeneic Hematopoietic Stem Cell Transplantation
COMPLETED60 Analytics
PHASE1COMPLETED
A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
Allogeneic Hematopoietic Stem Cell Transplantation
NCT0499565360
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Study Endpoints

Primary Endpoints

Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest
Day 100

Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest

Engraftment of SER-155
Day 100

Prevalence of SER-155 strains in subject stool measured before and after treatment courses

Secondary Endpoints

Abundance of Enterococcus and Enterobacteriaceae
Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
Day 100
Incidence and duration of febrile neutropenia
Day 100
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 - Open Label StudyEXPERIMENTALVancomycin \& SER-155
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled StudyEXPERIMENTALVancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo

Interventions

NameTypeDescription
Vancomycin Pre-TreatmentDRUGFour times daily dosing with Vancomycin
Vancomycin PlaceboDRUGFour times daily dosing with Vancomycin Placebo
SER-155DRUGOnce daily dosing with SER-155
SER-155 PlaceboDRUGOnce daily dosing with SER-155 placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Male and female subjects ≥ 18 years of age undergoing HSCT. * Planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unr...

Countries:United States
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