![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00403585 |
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (upto 3 years) adefovir dipivoxil 10mg therapy.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: adefovir dipivoxil 10mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase IV, Open Label, Single Arm, Multicenter, Extension Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814 |
Estimated Enrollment: | 80 |
Study Start Date: | July 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
child-bearing potential, has a negative serum pregnancy test at enrolment to this extension study, and agrees to one of the following:
Exclusion Criteria:
Previous or current lamivudine or antiviral therapy with agents demonstrating potential anti-HBV activity except ongoing adefovir dipivoxil treatment (e.g., HBIg, famciclovir, emtricitabine, DAPD, LFMAU, entecavir, ganciclovir, L-dC, L-dT or any others)
Clinical signs of decompensated liver disease as indicated by any one of the following, but not limited to :
Inadequate haematological function defined by any of the following :
Hepatocellular carcinoma as evidenced by one of the following:
Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
Planned for liver transplantation Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) can be expected during the course of the study.
History of hypersensitivity to nucleoside and/or nucleotide analogues. Inability to comply with study requirements as determined by the study investigator.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ADF108005, ADF 103814 extension study |
Study First Received: | November 23, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00403585 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Chronic Hepatitis B (CHB) Adefovir Dipivoxil(Hepsera) |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |