ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00294489
Recruitment Status : Unknown
Verified February 2006 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : February 22, 2006
Last Update Posted : February 22, 2006
Sponsor:
Information provided by:
Hadassah Medical Organization

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.

Condition or disease
Chronic Hepatitis C Virus Infection

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
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
Study Start Date : February 2006
Estimated Study Completion Date : December 2006




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00294489     History of Changes
Other Study ID Numbers: ORHCV1-HMO-CTIL
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: February 2006

Keywords provided by Hadassah Medical Organization:
HCV
Fibrosis
Breath test

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