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:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00158704
First received: September 7, 2005
Last updated: March 7, 2007
Last verified: April 2006
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: 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. |
Resource links provided by NLM:
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 |
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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00158704 History of Changes |
| Other Study ID Numbers: | GS-00-480 |
| Study First Received: | September 7, 2005 |
| Last Updated: | March 7, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Chronic Hepatitis B |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |
Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 23, 2013