NCT00263614

Brief Summary

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 3, 2009

Status Verified

January 1, 2009

First QC Date

December 8, 2005

Last Update Submit

January 30, 2009

Conditions

Chronic Hepatitis B

Eligibility Criteria

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

You may not qualify if:

  • History or evidence of HIV, hepatitic C, or hepatitis D. Other causes for liver disease other than hepatitis B, including but not limited to: hemochromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Drug-related liver disease, Autoimmune hepatitis, Alcoholic liver disease, Obesity-induced liver disease (nonalcoholic seatohepatitis, NASH). History of, or current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory or biopsy results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilead Sciences, Inc.

Foster City, California, 94404, United States

Location

Related Publications (1)

  • Hu KQ, Schiff ER, Kowdley KV, Min AD, Shiffman ML, Lee WM, Goodman ZD, Dau LO, Peschell KJ, Fagan EA, Flaherty JF. Histologic evidence of active liver injury in chronic hepatitis B patients with normal range or minimally elevated alanine aminotransferase levels. J Clin Gastroenterol. 2010 Aug;44(7):510-6. doi: 10.1097/MCG.0b013e3181d34c65.

    PMID: 20179614DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Flaherty, PharmD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 9, 2005

Study Start

December 1, 2005

Study Completion

June 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-01

Locations

US(1)