CompletedPhase 1

MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy

Israel19 participantsStarted 2013-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.-

What they're measuring

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

Timeframe: 7 days

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

Timeframe: 7 days

MBT correlation to clinical events after 2 month of treatment

Timeframe: 67 days

Trial details

NCT IDNCT01851252

SponsorMeridian Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

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