Prediction Value of the BreathID 13C-Methacetin Breath Te... | NCT02084160

NCT02084160

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
CLD from HIS-EX-408/PLT-BID-1108		Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatic Decompensation Event	Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: Death (liver related) Transplantation (cadaveric and living donors) Ascites HE (Hepatic Encephalopathy) Newly diagnosed varices or variceal bleeding SBP (spontaneous bacterial peritonitis) HRS (Hepatorenal syndrome) HCC (hepatocellular carcinoma) Increase in CTP (Child Turcotte Pugh) Score by 3 points Increase in MELD score by 5 points	5 years

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Taufick Chori, MD	Hadassah Medical Organization	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Health System		Detroit	Michigan	48202	United States
Medical University of South Carolina

ID	Title	Description
FG000	CLD From HIS-EX-408/PLT-BID-1108	Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000579 subjects
COMPLETED	579 patient records were reviewed for follow up events, only a small portion had events to report	FG000579 subjects
NOT COMPLETED		FG0000 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	CLD From HIS-EX-408/PLT-BID-1108	Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Hepatic Decompensation Event

Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection:

Death (liver related)
Transplantation (cadaveric and living donors)
Ascites
HE (Hepatic Encephalopathy)
Newly diagnosed varices or variceal bleeding
SBP (spontaneous bacterial peritonitis)
HRS (Hepatorenal syndrome)
HCC (hepatocellular carcinoma)
Increase in CTP (Child Turcotte Pugh) Score by 3 points
Increase in MELD score by 5 points

Patients with advanced chronic liver disease

Posted

Number

number of events

5 years

ID	Title	Description
OG000	CLD From HIS-EX-408/PLT-BID-1108	Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CLD From HIS-EX-408/PLT-BID-1108	Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

More Info Module

Certain Agreements