Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.
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.
1 other identifier
observational
107
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2003
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedJanuary 7, 2014
January 1, 2014
3 years
September 7, 2005
January 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Week 144
Secondary Outcomes (1)
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.
Baseline to Week 144
Interventions
Eligibility Criteria
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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
April 1, 2003
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
January 7, 2014
Record last verified: 2014-01