MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
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|ClinicalTrials.gov Identifier: NCT01851252|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Liver Disease Cirrhosis Esophageal Varices Portal Hypertension Bleeding||Device: Methacetin (with Breath testing device)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|Carmel Medical Center|
|Haifa, Israel, 34362|
|Principal Investigator:||Eyal Ashkenazi, M.D.||Carmel Medical Center|