MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy

NCT01851252 | Completed Phase 1

• 1 other identifier: HVPG-BB-EX-513
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect on the (carbon 13 labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker (NSBB) following initial administration and after chronic use of each of these agents. The correlation of the MBT with Hepatic Venous Pressure Gradient (HVPG) measurement before and after treatment will be assessed. Additionally, the MBT measurements following 60 days of therapy will be compared to the first MBT measurement and to the second MBT measurement, post HVPG. Each patient's subsequent MBT measurement will be compared to his previous MBT results in order to determine his/her response to therapy.

Conditions

Chronic Liver Disease; Cirrhosis; Esophageal Varices; Portal Hypertension; Bleeding

Keywords

Cirrhotics; Esophageal varices; Portal Hypertension

Outcome Measures

Primary Outcomes (3)

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

  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.

  7 days

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

  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.

  7 days

• MBT correlation to clinical events after 2 month of treatment

  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.

  67 days

Study Arms (1)

Methacetin (for BT) before / after Propanolol treatment.

EXPERIMENTAL

The 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.

Device: Methacetin (with Breath testing device)

Interventions

Methacetin (with Breath testing device) DEVICE

The 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.

Methacetin (for BT) before / after Propanolol treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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 splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets \<100,000/mm3, albumin\< 3.5g/dL, or international normalized ratio (INR)\>1.3) iii. Presence of esophageal varices (without previous variceal bleeding episode) or HVPG≥10mmHg 12mmHg from previous testing.
• Has been scheduled for hemodynamic study testing, including response to acute therapy.-

You may not qualify if:

• Patients already receiving beta blockers
• Hepatocellular carcinoma
• Portal vein thrombosis
• Contraindications to non-selective beta blocker Propanolol
• Cholestatic liver disease
• Severe heart, pulmonary or renal disease.
• Patient has previous surgical bypass surgery for morbid obesity
• Patient has extensive small bowel resection
• Any major surgery in the past 3 months.
• Patient is a recipient of any organ transplant
• Patient allergic to acetaminophen.
• Patients who are taking hepatotoxic drugs
• Patient, based on the opinion of the investigator, should not be enrolled into this study.
• Patients unable or unwilling to sign informed consent
• Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

Related Publications (25)

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MeSH Terms

Conditions

Fibrosis; Esophageal and Gastric Varices; Hypertension, Portal; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Study Officials

• Eyal Ashkenazi, M.D.

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

IL (1)