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

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00158704
• Collaborator: (none)
• Enrollment: 400
• Duration (Months): 36

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2002
• Study Completion Date: Jan 1, 2005

Outcome Measures

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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website for Gilead

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00158704
• Other Study ID Numbers: GS-00-480
• First Posted: Sep 12, 2005
• Last Update Posted: Mar 8, 2007
• Last Verified: Apr 1, 2006

• Keywords provided by , ,: Chronic Hepatitis B
• Additional relevant MeSH terms: Hepatitis B; Hepatitis; Adefovir dipivoxil

Study Results

No Results Posted as of Mar 8, 2007