NCT00294489

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 22, 2006

Status Verified

February 1, 2006

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

Chronic Hepatitis C Virus Infection

Keywords

HCVFibrosisBreath test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Related Publications (1)

  • Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.

    PMID: 15679768BACKGROUND

Related Links

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gadi Lalazar, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gadi Lalazar, MD

CONTACT

00 972 6778511lalazar@hadassah.org.il

Arik Tzukert, DMD

CONTACT

00 972 2 6776095arik@hadassah.org.il

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2006

Last Updated

February 22, 2006

Record last verified: 2006-02

Locations

IL(1)