Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

NCT ID: NCT01590615

Last Updated: 2017-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-26

Study Completion Date

2017-04-04

Brief Summary

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This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with chronic HBV infection

Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study.

Anti-HBV nucleoside/nucleotide therapy

Intervention Type DRUG

Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.

Interventions

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Anti-HBV nucleoside/nucleotide therapy

Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
* Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
* No history of solid organ or bone marrow transplant
* Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Cedars-Sinai Medical Center for Liver Diseases and Transplantation

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

University of California at San Francisco Medical Center

San Francisco, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Florida Hospital Transplant

Orlando, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Alegent Creighton Health

Omaha, Nebraska, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Methodist University Hospital

Memphis, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Baylor All Saints Medical Center

Fort Worth, Texas, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, Canada

Site Status

Toronto Liver Centre

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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GX-US-174-0172

Identifier Type: -

Identifier Source: org_study_id

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