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

Gilead Sciences400 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Hepatitis B

Interventions

HepseraDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

To evaluate the safety of chronic therapy with ADV 10 mg.

Data from ClinicalTrials.gov

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