Status:

UNKNOWN

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

Lead Sponsor:

Hadassah Medical Organization

Conditions:

Chronic Hepatitis C Virus Infection

Eligibility:

All Genders

18+ years

Brief Summary

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 pr...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2006

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT00294489

Start Date

February 1 2006

End Date

December 1 2006

Last Update

February 22 2006

Active Locations (1)

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Hadassah Medical Organization

Jerusalem, Israel, 91120