Status:
COMPLETED
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
Lead Sponsor:
Meridian Bioscience, Inc.
Conditions:
Chronic Liver Disease
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 administrat...
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...
Eligibility Criteria
Inclusion
- \> 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01851252
Start Date
October 1 2013
End Date
August 1 2017
Last Update
December 20 2022
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel, 34362