Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102213
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2023-10-09
Brief Title:
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
Sponsor:
Prolacta Bioscience
Organization:
Prolacta Bioscience
Study Overview
Official Title:
A Randomized Open-Label Multicenter Phase 2a Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation Allo-HCT
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor business decision to terminate the study early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2a open-label multicenter study to evaluate the safety and efficacy of HMO PBCLN-010 and B infantis PBCLN-014 on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT
Approximately 60 participants will be enrolled in this study and all participants will undergo screening assessments up to 28 days before the first study drug dose D 7 Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts
Cohort A HMO 90 g and B infantis BID
Cohort B HMO 45 g and B infantis BID
Cohort C Control Cohort Participants in this cohort will not receive any study drug
Approximately 60 participants will be enrolled in this study and all participants will undergo screening assessments up to 28 days before the first study drug dose D 7 Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts
Cohort A HMO 90 g and B infantis BID
Cohort B HMO 45 g and B infantis BID
Cohort C Control Cohort Participants in this cohort will not receive any study drug
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None