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Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00158704
Recruitment Status : Terminated (The study stopped due to marketing approval by the FDA.)
First Posted : September 12, 2005
Last Update Posted : March 8, 2007
Sponsor:
Information provided by:
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Hepsera Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2002
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate the safety of chronic therapy with ADV 10 mg.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00158704    
Other Study ID Numbers: GS-00-480
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 8, 2007
Last Verified: April 2006
Keywords provided by Gilead Sciences:
Chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Blood-Borne Infections
Communicable Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action