NCT00350714

Brief Summary

The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (\>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled substrate (13C-methacetin) in real time.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
terminated

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

July 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 10, 2006

Last Update Submit

December 19, 2022

Conditions

Hepatitis C

Keywords

HCV (Hepatitis C Virus)MBT (Methacetin Breath Test)Hepatitis C Virus Patients

Outcome Measures

Primary Outcomes (1)

  • Correlation of Breath Test (MBT) to Fibrosis

    13 C Lebeled substrate is metabolized by Liver and reflects liver function. It is hypothesized that this correlated to liver fibrosis

    12 months

Study Arms (1)

MBT

EXPERIMENTAL

C13 methacetin dissolved in water to be ingested after breath baseline collected. Metabolism to measured in real time.

Other: MBT and BreathID

Interventions

MBT and BreathIDOTHER

75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion.

MBT

Eligibility Criteria

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

You may qualify if:

  • i. Patients with a confirmed diagnosis of Chronic HCV only : ii. Patients for whom a liver biopsy has been performed within the last 90 days or who will undergo a liver biopsy within the time frame of the study.

You may not qualify if:

  • i. Severe congestive heart failure. ii. Severe pulmonary hypertension. iii.Chronic renal insufficiency defined by a serum creatinine above the limits of normal. iv. Uncontrolled diabetes mellitus (need definition).v.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. vi.Proven or suspected hepatocellular carcinoma. vii. Previous surgical bypass surgery for morbid obesity viii.Extensive small bowel resection. ix.Patients currently receiving total parenteral nutrition x.Recipients of any organ transplant. xi.Other co-existent liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center

Richmond, Virginia, 23249-0001, United States

Location

Virginia Commonwealth Univeristy

Richmond, Virginia, 23284, United States

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • O. Goetze; N. Selzner; A. Grau; M. Fried; T. Gerlach; B. Muellhaupt 13C-Methacetin Breath Test by Online Molecular Correlation Spectroscopy Compared to APRI and Liver Biopsy for the Assessment of Fibrosis in Chronic Hepatitis C , S1047. Abstarct presented at DDW 2006

    RESULT

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Doug Dieterich, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • John M Vierling, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Mitchell Shiffman, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • Maya Margalit, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Douglas M. Heuman, M.D.

    U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 11, 2006

Study Start

July 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

US(4)IL(1)