Back to resultsStudy of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
Primary Purpose
Hepatitis B, Chronic, Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
adefovir dipivoxil 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Adefovir Dipivoxil(Hepsera), Chronic Hepatitis B (CHB)
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
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.
Secondary Outcome Measures
Number of Participants Achieving ALT Normalization at Week 104 & 156
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
Virological response is defined as HBV DNA level<300 copies/ml
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
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
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
The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00403585
Brief Title
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic, Chronic Hepatitis B
Keywords
Adefovir Dipivoxil(Hepsera), Chronic Hepatitis B (CHB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
adefovir dipivoxil 10mg
Primary Outcome Measure Information:
Title
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
Description
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.
Time Frame
Baseline, Week 156
Secondary Outcome Measure Information:
Title
Number of Participants Achieving ALT Normalization at Week 104 & 156
Description
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.
Time Frame
Week 104, Week 156
Title
Number of Participants Achieving Virological Response at Week 104 & 156
Description
Virological response is defined as HBV DNA level<300 copies/ml
Time Frame
Week 104, Week 156
Title
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Description
Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
Time Frame
Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156
Title
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Description
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.
Time Frame
Week 104 and 156
Title
Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event
Description
The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
Time Frame
Treatment Phase (Weeks 53-156)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, M.D., Ph.D
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
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