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Methacetin

Phase 1

Chronic Liver Disease | Unknown | Hematology |Meridian Bioscience Inc|Last Updated: Dec 20, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Methacetin · 1 trial · 5 indications

Phase 1 1
NCT01851252MBT Versus HVPG in Identifying Responders to Portal Hypertension TherapyChronic Liver Disease
COMPLETED19 Analytics
PHASE1COMPLETED
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
Chronic Liver DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Correlation between HVPG and MBT and their changes following the i.v. administration of Propranolol
7 days

MBT baseline measure will be measured within a week before the anticipated HVPG procedure, but not on the same day. The HVPG will be measured approximately 30 minutes after i.v. propanolol is given and the MBT will be performed approximately one hour later.

The changes between MBT at baseline level and after chronic treatment in Propranolol
7 days

MBT baseline measure will be measured within a week before the anticipated HVPG procedure, but not on the same day. The HVPG will be measured approximately 30 minutes after i.v. propanolol is given and the MBT will be performed approximately one hour later.

MBT correlation to clinical events after 2 month of treatment
67 days

The MBT will be performed on subjects again after 60 days of oral beta blocker treatment and its results will be compared to previous MBT values.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Methacetin (for BT) before / after Propanolol treatment.EXPERIMENTALThe methacetin breath test (MBT) will be performed before and after (within 2 hours) injection of Propanolol (BB) dose and once again after 60 days of oral administration of Propanolol.

Interventions

NameTypeDescription
Methacetin (with Breath testing device)DEVICEThe methacetin is enriched with carbon 13, a stable non- radioactive isotope, and has been found to be safe in hundreds of studies. The material is very similar to acetominophen. 75 milligrams (mm) of this material pre- dissolved in water are used. This material undergoes rapid metabolism by the liver.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: -\> 18 years old (M/F) -Diagnosis of cirrhosis: i. By liver biopsy ii. Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable spleno...

Countries:Israel
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Frequently asked questions about Methacetin

What is Methacetin used for?

Methacetin is an investigational drug being studied for use in chronic liver disease, including cirrhosis, esophageal varices, portal hypertension, and bleeding. It is currently in Phase 1 clinical development.

Who makes Methacetin?

Methacetin is being developed by Meridian Bioscience Inc, a company traded under the ticker VIVO.

What phase is Methacetin in?

Methacetin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA.

What clinical trials is Methacetin in?

Methacetin has one completed clinical trial, NCT01851252, titled 'MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy.' The trial enrolled 19 participants with chronic liver disease and related conditions in Israel.

Is Methacetin the same as MBT?

Methacetin is also referred to as MBT, as indicated by the clinical trial title 'MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy.'