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

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, February 2006

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00294489

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 III

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

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

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, Jerusalem, Israel

More Information

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

Publications:

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.

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

Keywords provided by Hadassah Medical Organization:

HCV
Fibrosis
Breath test

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Fibrosis
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009