Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT

February 21, 2006 updated by: Hadassah Medical Organization
A relatively large proportion of patients with chronic HCV infection have normal or mildly elevated ALT. Many of these patients are not being treated, and are not being sent for a liver biopsy. The present study will determine the ability of Methcetin BreathID Test(MBIT) to detect those patients who will be candidates for anti-viral treatment, as an alternative measure for liver biopsy in decision-making prior to treatment in clinical hepatology.

Study Overview

Status

Unknown

Conditions

Detailed Description

The rational for using MBIT in the management of HCV in patients with persistently normal (and slightly elevated) ALT:

  • If MBIT is impaired, this indicates fibrosis >2: a trigger to begin treatment
  • This strategy will enable treating patients with relatively severe disease that was not detected by biopsy.
  • HMOs recognize the cost-effectiveness of anti-viral therapy in these patients, as a means of prevention of deterioration, cirrhosis and HCC.
  • If MBIT indicates low fibrosis => treatment may be deferred, and follow-up is performed to detect any possible degradation that will indicate need for treatment.
  • Today the AASLD guidelines allow for treatment of HCV RNA+ patients with normal ALT. In view of the limited effectivity of therapy, its cost and side effects, there are likely to be many individuals in whom therapy can be safely deferred, leading to cost saving.
  • MBIT may replace the need of liver biopsy for decision- making in HCV.
  • Even in patients with genotype 1 and elevated ALT, or with risk of side effects, treatment may be delayed in low fibrosis (e.g. <2).

GOAL:

• To assess the ability of the MBIT to improve the management of patients for liver disorders

AIM:

• To determine whether the Methacetin BreathID Test (MBIT) can be useful in evaluation of HCV RNA positive patients with normal or minimally elevated ALT and to determine the severity of their liver disease as a guide for decision-making in routine clinical use.

OBJECTIVE:

AUC>0.75 (+/-10% in 95%CI) in detection of fibrosis>2.

INCLUSION CRITERIA:

  • Men or women>18
  • Patients with HCV RNA+ above 105 copies Patients with normal liver enzymes on two tests 3 months apart, or up to <X1.5 of upper normal
  • Patients with biopsy proven HCV or (9 months prior to test with no anticipated changes in liver disease since biopsy).

EXCLUSION CRITERIA:

  • Other liver disorders.
  • Active infections.
  • Use of drugs that are known to induce/suppress P4501A2
  • Pulmonary diseases
  • Consumption of >20cc alcohol a day prior to the test.

NUMBER OF PATIENTS:

  • 200 HCV
  • 50 matched controls

METHODS:

  • Patient selection - All the patients that underwent a liver biopsy in the last 9 months in each center are invited to participate in the study, assuming they meet inclusion/exclusion criteria.
  • Patients will undergo MBIT and data will be compared with the results of the different fibrotic and inflammatory scores (i.e. METAVIR) on liver biopsy. One pathologist will re-examine all biopsies.
  • Oridion BreathID will provide MBIT data on 50 healthy controls.
  • Substrate - A test meal consisting of 75mg PO methacetin + a known surface-active ingredient routinely used in the food and drug industry.
  • Test length - 1 hour
  • Fasting-8 hours fast only.
  • The patient will be attached to the BreathID device via a nasal cannula and after baseline breath is measured, the test meal will be ingested and the device will continue measuring the exhaled breath for 1 hour. The BreathID device automatically measures changes in the 13C/12C ratio due to metabolization of the methacetin, using a spectroscopic principal. The results are printed out automatically at the end of the test.

STUDY DESIGN:

• At first visit to physician, patients will perform viral load test, liver enzymes tests and MBIT. A biopsy will have been performed within 9 months of these tests.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Principal Investigator:
          • Gadi Lalazar, MD
        • Sub-Investigator:
          • Tiberiu Hershcovici, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women>18
  • Patients with HCV RNA+ above 105 copies Patients with normal liver enzymes on two tests 3 months apart, or up to <X1.5 of upper normal
  • Patients with biopsy proven HCV or (9 months prior to test with no anticipated changes in liver disease since biopsy).

Exclusion Criteria:

  • Other liver disorders.
  • Active infections.
  • Use of drugs that are known to induce/suppress P4501A2
  • Pulmonary diseases
  • Consumption of >20cc alcohol a day prior to the test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

December 1, 2006

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 21, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORHCV1-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C Virus Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe