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
Time Perspective: Longitudinal
Official Title: Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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:
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 August 21, 2014