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Clinical Trials/EUCTR2014-002037-59-ES
EUCTR2014-002037-59-ES
Active, not recruiting
Phase 1

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 - Protocol Number: CSPH-EX-0414

Exalenz BioScience Ltd.0 sites200 target enrollmentSeptember 11, 2014
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Exalenz BioScience Ltd.
Enrollment
200
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 11, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Exalenz BioScience Ltd.

Eligibility Criteria

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)

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

Outcomes

Primary Outcomes

Not specified

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