Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
This study has been terminated.
(The study stopped due to marketing approval by the FDA.)
Information provided by:
First received: September 7, 2005
Last updated: March 7, 2007
Last verified: April 2006
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.
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- 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 Outcome Measures:
- To evaluate the safety of chronic therapy with ADV 10 mg.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
The objective of this study is to provide adefovir dipivoxil 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. The secondary objective of this study is to evaluate the safety of chronic therapy with adefovir dipivoxil 10 mg.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2005
||March 7, 2007
||United States: Food and Drug Administration
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action