Cirrhosis Clinical Trial
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
Verified date | December 2022 |
Source | Meridian Bioscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Meridian Bioscience, Inc. |
Israel,
Abraldes JG, Tarantino I, Turnes J, Garcia-Pagan JC, Rodes J, Bosch J. Hemodynamic response to pharmacological treatment of portal hypertension and long-term prognosis of cirrhosis. Hepatology. 2003 Apr;37(4):902-8. doi: 10.1053/jhep.2003.50133. — View Citation
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Groszmann RJ, Bosch J, Grace ND, Conn HO, Garcia-Tsao G, Navasa M, Alberts J, Rodes J, Fischer R, Bermann M, et al. Hemodynamic events in a prospective randomized trial of propranolol versus placebo in the prevention of a first variceal hemorrhage. Gastroenterology. 1990 Nov;99(5):1401-7. doi: 10.1016/0016-5085(90)91168-6. — View Citation
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La Mura V, Abraldes JG, Raffa S, Retto O, Berzigotti A, Garcia-Pagan JC, Bosch J. Prognostic value of acute hemodynamic response to i.v. propranolol in patients with cirrhosis and portal hypertension. J Hepatol. 2009 Aug;51(2):279-87. doi: 10.1016/j.jhep.2009.04.015. Epub 2009 May 24. — View Citation
Merkel C, Bolognesi M, Sacerdoti D, Bombonato G, Bellini B, Bighin R, Gatta A. The hemodynamic response to medical treatment of portal hypertension as a predictor of clinical effectiveness in the primary prophylaxis of variceal bleeding in cirrhosis. Hepatology. 2000 Nov;32(5):930-4. doi: 10.1053/jhep.2000.19322. — View Citation
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Turnes J, Garcia-Pagan JC, Abraldes JG, Hernandez-Guerra M, Dell'Era A, Bosch J. Pharmacological reduction of portal pressure and long-term risk of first variceal bleeding in patients with cirrhosis. Am J Gastroenterol. 2006 Mar;101(3):506-12. doi: 10.1111/j.1572-0241.2006.00453.x. — View Citation
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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