Brief description of trial (Data source: BASEC)
Diese Studie ist eine multizentrische, nicht randomisierte, exploratorische Studie, in der verschiedene MBT (Methacetin Atemtest)-Messungen mit HVPG (Venenverschlussdruck-Gradienten - hepatic venous pressure gradient) verglichen werden. Diese Studie dient dem Training eines Algorithmus anhand der MBT-Messungen und der Auswahl eines Wertes zur Bestimmung der Anwesenheit oder Abwesenheit einer klinisch signifikanten Portalen Hypertonie (CSPH). Der MBT wird innerhalb von 7 Tagen vor oder nach dem standardisierten HVPG-Verfahren durch Einnahme einer einzigen 75-mg-Dosis 13C-Methacetin durchgeführt.
Primärer Wirksamkeitsendpunkt ist die Diagnose einer CSPH (definiert mittels HVPG ≥10 mmHg), die mit einem MBT-Ergebnis korreliert. Die Beziehung wird sowohl bei Patienten mit und ohne CSPH untersucht, um ein klinisch signifikantes MBT-Modell/-Algorithmus und seinen Cutoff-Wert zu gewinnen, der in einer getrennten Studie validiert werden soll.
Sicherheitsendpunkt: Berichten unerwünschter Ereignisse.
Health conditions investigated(Data source: BASEC)
Diagnose der schweren portalen Hypertonie in der Leber (erhöhter Druck in der Pfortader)
Health conditions
(Data source: WHO)
Patients With Compensated Liver Cirrhosis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Der MBT wird innerhalb von 7 Tagen vor oder nach dem standardisierten HVPG-Verfahren durch Anwendung einer einzigen 75-mg-Dosis 13C-Methacetin durchgeführt.
Interventions
(Data source: WHO)
Device: Methacetin Breath Test
Criteria for participation in trial
(Data source: BASEC)
1. Erwachsene Männer oder Frauen (>18 Jahre alt)
2. Patient kann eine Einwilligungserklärung unterschreiben
3. Bekannte chronische Lebererkrankung mit Zirrhose
4. Indikation zur Durchführung eines HVPG-Tests
Exclusion criteria
(Data source: BASEC)
1. Dekompensierte Zirrhose
2. Niereninsuffizienz (Kreatinin > 2,5 mg/dl)
3. Bekannte akute Nierentubuluserkrankung
4. Bekannte Hypotonie (systolischer Blutdruck < 100 mmHg)
Inclusion/Exclusion Criteria
(Data source: WHO)
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
-
Further information on trial
Date trial registered
May 18, 2014
Incorporation of the first participant
Nov 1, 2014
Recruitment status
Completed
Academic title
(Data source: WHO)
Clinical Study of the BreathID® LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
CSPH (Clinically Significant Portal Hypertension)
Secundary end point
(Data source: WHO)
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern
Countries
(Data source: WHO)
France, Spain, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Annalisa Berzigotti
+41 31 632 80 26
annalisa.berzigotti@insel.ch
Contact for general information
(Data source: WHO)
Juan Carlos Garcia Pagan, MD
University Hospital Barcelona
Contact for scientific information
(Data source: WHO)
Juan Carlos Garcia Pagan, MD
University Hospital Barcelona
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
08.06.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-00524
Secondary ID (Data source: WHO)
2014-002037-59
CSPH-EX-4014
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