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. )

First Received: September 7, 2005 Last Updated: March 7, 2007 History of Changes

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00158704

Purpose

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.

Condition	Intervention
Hepatitis B	Drug: Hepsera

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Adefovir dipivoxil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Gilead Sciences:

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:	400
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2005

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Website for Hepsera This link exits the ClinicalTrials.gov site

Website for Gilead This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GS-00-480
Study First Received:	September 7, 2005
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00158704 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Chronic Hepatitis B

Study placed in the following topic categories:

Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Antiviral Agents
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases

Digestive System Diseases
Anti-Retroviral Agents
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 06, 2009