Study Stopped
The study stopped due to marketing approval by the FDA.
Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
An Open-Label, Continued Access Study of Adefovir Dipivoxil for Patients With Chronic HBV Infection Who Have Completed a Gilead-Sponsored Study of Adefovir Dipivoxil.
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2002
Typical duration for not_applicable
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
January 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedMarch 8, 2007
April 1, 2006
September 7, 2005
March 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide adefovir dipivoxil (ADV) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study and require continued access to ADV.
Secondary Outcomes (1)
To evaluate the safety of chronic therapy with ADV 10 mg.
Interventions
Eligibility Criteria
You may qualify if:
- Must have completed one of the following Gilead-sponsored studies as indicated: GS-96-412, GS-98-437, GS-98-438, GS-00-461 and GS-00-481. If the patient has participated in another Gilead-sponsored study, the CRO or Sponsor's Medical Monitor will evaluate for participation in this study on a case by case basis.
You may not qualify if:
- Any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements.
- Currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil.
- Currently receiving investigational agents with activity against hepatitis B virus.
- Hypersensitivity to any of the components of the drug product.
- Pregnant or lactating females.
- Inability to comply with study requirements.
- Experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
January 1, 2002
Study Completion
January 1, 2005
Last Updated
March 8, 2007
Record last verified: 2006-04