Klinische Studie über das BreathID MCS-System zur Entwicklung einer Diagnosetechnik für den Nachweis einer schwereren portalen Hypertonie in der Leber

Device: Methacetin Breath Test

Inclusion Criteria:

- Adult men or women (>18 years of age)

- Known chronic liver disease with cirrhosis

- Europe: Indicated to undergo HVPG testing

- US: Consented for HVPG

- 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

- For patients who stopped their treatment with beta blockers: Their last dose should be
at least 6 weeks prior to any study related tasks

Exclusion Criteria:

- Decompensated cirrhosis as clinically defined by the presence of ascites, hepatic
encephalopathy, variceal bleeding or hepatorenal syndrome

- Renal failure (creatinine > 2.5 mg/dl)

- Known acute renal tubular disease Known hypotension (Systolic Pressure <100mmHg)

- Hypocoagulablity defined as PT >6 and INR >2.3.

- Congestive heart failure (assessed clinically as NIHA >2)

- Known pulmonary hypertension (right ventricular systolic pressure > 45 mm Hg)

- Uncontrolled diabetes mellitus (HBA1C >9.5gr%)

- Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to
treatment are not stable for at least 3 months.

- Documented or suspected hepatocellular carcinoma

- Gastric bypass surgery or extensive small bowel resection

- Total parenteral nutrition

- Any organ transplant recipient

- Pregnant or breast feeding

- Allergy to acetaminophen and/or other related medications

- Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or
drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)

- Uncontrolled malabsorption or diarrhea

- Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic
venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic
portosystemic shunt (TIPS)

- Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis,
hepatic sarcoidosis, or other cholestatic disorders

- Subjects unable to perform the MBT within 7 days of HVPG procedure.

- Subject should not have taken any of the following for at least 48 hours prior to the
breath test: Acyclovir , allopurinol, amiodarone, 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

- Subject should not have taken amiodarone or statins within the last 30 days prior to
the breath test or HVPG procedure