Clinical Study of the BreathID LF System to develop a diagnosis technique to Detect Severe Portal Hypertension in the Liver

Phase 1

• Conditions: Compensated Liver Cirrhosis and indication to undergo HVPG testing; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-002037-59-ES
• Lead Sponsor: Exalenz BioScience Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Adult men or women (>18 years of age)
2.Able (or legal guardian) and willing to sign an Informed Consent Form
3.Known chronic liver disease with cirrhosis confirmed by either:
a.liver biopsy or
b.clinical (palpable left lobe, splenomegaly) and laboratory (platelets <150,000/mm3 or albumin< 3.8g/dL, or INR >1.3) evidence of cirrhosis and/or
c.imaging studies by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or enlarged spleen and/or portosystemic collaterals with portal vein patency and/or minimal ascites, and/or colloid shift on a colloid-isotope liver-spleen scan or measurements of liver stiffness suggestive of cirrhosis

4.Indicated to undergo HVPG testing
5.Can tolerate an overnight (8-hour) fast
6.For patients treated with beta blockers: They have to be on a stable dose for at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
7.For patients who stopped their treatment with beta blockers: Their last dose should be at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Decompensated cirrhosis as clinically defined by the occurrence of any of the following: ascites, hepatic encephalopathy, variceal bleeding or hepatorenal syndrome
2.Renal failure (creatinine > 2.5 mg/dl)
3.Known acute renal tubular disease
4.Known hypotension (Systolic Pressure <100mmHg)
5.Hypocoagulablity defined as PT >6 and INR >2.3.
6.Congestive heart failure (assessed clinically as NIHA >2)
7.Known pulmonary hypertension (right ventricular systolic pressure > 45 mm Hg)
8.Uncontrolled diabetes mellitus (HBA1C >9.5gr%)
9.Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to treatment are not stable for at least 3 months.
10.Documented hepatocellular carcinoma lesion larger than 3cm and/or multifocal lesions and/or evidence of vascular invasions
11.Gastric bypass surgery or extensive small bowel resection
12.Total parenteral nutrition
13.Any organ transplant recipient
14.Pregnant or breast feeding
15.Allergy to acetaminophen and/or other related medications.
16.Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)
17.Uncontrolled malabsorption or diarrhea
18.Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic portosystemic shunt (TIPS)
19.Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis, hepatic sarcoidosis, or other cholestatic disorders
20.Subjects unable to perform the MBT within 7 days of HVPG procedure.
21.Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir , allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
22.Subject should not have taken amiodarone or statins within the last 30 days prior to the breath test or HVPG procedure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified