Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03611101
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2018-07-19
Brief Title:
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS NCT03486899 NCT03486912 Referenced Trials
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
Companion Protocol for the ¹³C-Methacetin Breath Test MBT for Use in Bristol-Myers Squibb Phase 2b Studies for BMS-986036 PEG-FGF21 Under Studies Referenced in NCT03486899 NCT03486912
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a companion study assessing the ¹³C-Methacetin Breath Test MBT in subjects participating in the Bristol Myers-Squibb BMS NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036
Detailed Description:
Subjects that are enrolled into either of two separate BMS sponsored IND Investigational New Drug studies referenced by NCT03486899 and NCT03486912 at selected study sites will be offered the opportunity to perform the MBT These will be considered as two separate study cohorts cohort 1 and 2 respectively within this companion protocol There are four 4 treatment arms BMS-986036 Dose Level 1 Dose Level 2 Dose Level 3 or matching placebo as defined in the respective BMS sponsored protocols
Cohort 1 consists of Subjects with NASH and stage 3 fibrosis as assessed by a central laboratory reader of the liver biopsies up to 160 and who meet all the NCT03486899 referenced study criteria
Cohort 2 consists of Subjects with NASH and compensated liver cirrhosis as assessed by a central laboratory reader of the liver biopsies up to100 and who meet all the NCT03486912 referenced study criteria
Approximately 75 sites will be included in the BMS studies but not all participating sites will elect to perform the MBT Each subject will perform up to 3 MBTs over 1 year approximately one every 24 weeks
The MBT in this study will only be conducted in the USA
The primary purpose of the BMS study is to assess an experimental treatment for the following conditions Hepatic cirrhosis liver fibrosis Nonalcoholic Fatty Liver Disease NAFLD and NASH Nonalcoholic Steatohepatitis
Cohort 1 consists of Subjects with NASH and stage 3 fibrosis as assessed by a central laboratory reader of the liver biopsies up to 160 and who meet all the NCT03486899 referenced study criteria
Cohort 2 consists of Subjects with NASH and compensated liver cirrhosis as assessed by a central laboratory reader of the liver biopsies up to100 and who meet all the NCT03486912 referenced study criteria
Approximately 75 sites will be included in the BMS studies but not all participating sites will elect to perform the MBT Each subject will perform up to 3 MBTs over 1 year approximately one every 24 weeks
The MBT in this study will only be conducted in the USA
The primary purpose of the BMS study is to assess an experimental treatment for the following conditions Hepatic cirrhosis liver fibrosis Nonalcoholic Fatty Liver Disease NAFLD and NASH Nonalcoholic Steatohepatitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None