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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00294489
First received: February 21, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Phase
Chronic Hepatitis C Virus Infection
 Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 500
Study Start Date: February 2006
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294489

Contacts
Contact: Gadi Lalazar, MD 00 972 6778511 lalazar@hadassah.org.il
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Gadi Lalazar, MD            
Sub-Investigator: Tiberiu Hershcovici, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Gadi Lalazar, MD Hadassah Medical Organization
  More Information

Additional Information:
Company producing Breath ID machine and substances  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00294489     History of Changes
Other Study ID Numbers: ORHCV1-HMO-CTIL
Study First Received: February 21, 2006
Last Updated: February 21, 2006
Health Authority: United States: Food and Drug Administration
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
HCV
Fibrosis
Breath test

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013