Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.

January 6, 2014 updated by: Gilead Sciences

A Phase 3b, Long-Term, Observational Study of the Durability of Seroconversion in Patients With Chronic Hepatitis B Virus Infection Who Have Seroconverted While Participating in a Previous Gilead-Sponsored Study of Adefovir Dipivoxil.

To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

The secondary objective of this study is to investigate the durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

Study Type

Observational

Enrollment (Actual)

107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who demonstrate HBeAg seroconversion or durable HBeAg loss in one of the previous Gilead-sponsored studies listed in Section 4.2 of this protocol and meet all inclusion and none of the exclusion criteria for this study will be eligible for enrollment.

Description

Inclusion Criteria:

  • Must have met all inclusion criteria and none of the exclusion criteria and must have demonstrated HBeAg seroconversion or durable HBeAg loss as defined by the protocol in one of the following Gilead-sponsored studies: GS-96-412, GS-98-437, GS-00-461 or ongoing or future Gilead-sponsored studies identified by the Sponsor to be eligible for this study. Other patients who were enrolled in a now closed Gilead-sponsored study of ADV (GS-94-404, GS-96-412 Initial Phase or GS-96-413) and had previously demonstrated seroconversion or durable HBeAg loss during their participation will be evaluated by the clinical research organization (CRO) medical monitor for participation in this study on a case by case basis.
  • Have documented negative serum HBeAg with or without positive anti-HBe present at the two study visits prior to the final visit of the previous study.
  • A patient who has documented negative serum HBeAg without positive anti-HBe must also have undetectable serum HBV DNA (less than 1000 copies/mL using Roche Amplicor PCR Assay) and normalized ALT (less than ULN) confirmed during these two studies.
  • All patients must be able to give written informed consent and comply with requirements of this study.

Exclusion Criteria:

  • Patients who seroconvert or experience durable HBeAg loss during their participation in study GS-00-480 will not be eligible.
  • Any serious or active medical or psychiatric illness that, in the opinion of the investigator would interfere with patient treatment, assessment or compliance with the protocol.
  • Receiving any of the excluded medications listed in the protocol.
  • Inability to comply with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.
Time Frame: Baseline to Week 144
Baseline to Week 144

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability of HBeAg loss in patients with chronic hepatitis B virus infection (HBV) who have experienced durable HBeAg loss while participating in a previous Gilead-sponsored study of adefovir dipivoxil.
Time Frame: Baseline to Week 144
Baseline to Week 144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-00-481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Hepsera

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe