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MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01851252
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Cirrhosis Esophageal Varices Portal Hypertension Bleeding Device: Methacetin (with Breath testing device) Phase 1

Detailed Description:
Variceal bleeding is a life threatening complication of cirrhosis, which still carries a high mortality. Non selective beta-adrenergic blockers are effective at preventing first time variceal bleeding and re-bleeding. The efficacy of these drugs depends on the magnitude of reduction in portal pressure after administration, which varies widely between patients. Studies have shown that a reduction in portal pressure (as measured by HVPG) to 20% from baseline or to values ≤ 12 millimeters of mercury (mmHg) is associated with a low residual risk of bleeding . Patients with such a reduction are considered to be "responders" to beta blocker (BB) therapy. Unfortunately, a significant percentage of patients do not respond to therapy and need to be prescribed to an alternative therapy. The clinical application of this observation is limited since it requires a repeated HVPG measurement,which is not feasible in most cases. A non-invasive breath test that can assess portal pressure in correlation to HVPG and allow efficient management of patients at risk, could be very useful.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Evaluate the Correlation Between ¹³C Methacetin Breath Test (MBT) and HVPG Measurement as a Tool for Identifying Responders to Portal Hypertension Therapy
Actual Study Start Date : October 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methacetin (for BT) before / after Propanolol treatment.
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)
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.




Primary Outcome Measures :
  1. Correlation between HVPG and MBT and their changes following the i.v. administration of Propranolol [ Time Frame: 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.

  2. The changes between MBT at baseline level and after chronic treatment in Propranolol [ Time Frame: 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.

  3. MBT correlation to clinical events after 2 month of treatment [ Time Frame: 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.-

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851252


Locations
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Israel
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
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Principal Investigator: Eyal Ashkenazi, M.D. Carmel Medical Center
Additional Information:
Publications:

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Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01851252    
Other Study ID Numbers: HVPG-BB-EX-513
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: January 2017
Keywords provided by Exalenz Bioscience LTD.:
Cirrhotics
Esophageal varices
Portal Hypertension
Additional relevant MeSH terms:
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Liver Diseases
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases