Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
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Purpose
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 (up to 3 years) adefovir dipivoxil 10mg therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic Chronic Hepatitis B |
Drug: adefovir dipivoxil 10mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy [ Time Frame: Baseline, Week 156 ] [ Designated as safety issue: No ]HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
- Number of Participants Achieving ALT Normalization at Week 104 & 156 [ Time Frame: Week 104, Week 156 ] [ Designated as safety issue: No ]Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.
- Number of Participants Achieving Virological Response at Week 104 & 156 [ Time Frame: Week 104, Week 156 ] [ Designated as safety issue: No ]Virological response is defined as HBV DNA level<300 copies/ml
- HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 [ Time Frame: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156 ] [ Designated as safety issue: No ]Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
- Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 [ Time Frame: Week 104 and 156 ] [ Designated as safety issue: No ]Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.
- Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event [ Time Frame: Treatment Phase (Weeks 53-156) ] [ Designated as safety issue: No ]The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
| 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) |
-
Drug: adefovir dipivoxil 10mg
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has completed ADF103814 and continues with adefovir dipivoxil treatment via prescription without interruption prior enrolment in this extension study.
Availability and willingness of subject to provide written informed consent.
Exclusion Criteria:
Use of immunosuppressive therapy requiring use of more than 5mg of prednisolone(or equivalent) per day, immunomodulatory therapy (including interferon or thymosin) or systemic cytotoxic agents during the study.
Previous or current lamivudine or antiviral therapy Clinical signs of decompensated liver disease as indicated by the protocol Inadequate haematological function defined by the protocol - Documented evidence of active liver disease due to other causes Hepatocellular carcinoma as evidenced by the protocol Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders or cancer.
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 or competitors of renal excretion 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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00403585 History of Changes |
| Other Study ID Numbers: | ADF108005, update with ADF103814 |
| Study First Received: | November 23, 2006 |
| Results First Received: | April 24, 2009 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by GlaxoSmithKline:
|
Adefovir Dipivoxil(Hepsera) Chronic Hepatitis B (CHB) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic 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