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.)
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00158704
First received: September 7, 2005
Last updated: March 7, 2007
Last verified: April 2006

September 7, 2005
March 7, 2007
January 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00158704 on ClinicalTrials.gov Archive Site
To evaluate the safety of chronic therapy with ADV 10 mg.
Same as current
Not Provided
Not Provided
 
Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
Drug: Hepsera
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
January 2005
Not Provided

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00158704
GS-00-480
Not Provided
Not Provided
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP