Last updated: 11/04/2018 04:31:56
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase III study of Adefovir Dipivoxil tablets in patients with compensated chronic hepatitis B -Comparative study against Lamivudine-
Trial description: This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean Change from Baseline in Hepatitis B Virus (HBV) DNA at Week 52
Timeframe: Baseline and Week 52
Secondary outcomes:
Percentage of participants with HBV DNA Loss (<400 copies/mL) at Week 52
Timeframe: Week 52
Time to onset of HBV DNA loss (< 400 copies/mL)
Timeframe: From Baseline to Week 52
Percentage of participants with Hepatitis B e antigen (HBeAg) loss at Week 52
Timeframe: Week 52
Percentage of participants with Hepatitis B e antigen/antibody (HBeAg/Ab) Seroconversion at Week 52
Timeframe: Week 52
Time to onset of HBeAg loss
Timeframe: From Baseline to Week 52
Time to onset of HBeAg/Ab seroconversion
Timeframe: From Baseline to Week 52
Percentage of participants with Hepatitis B s antigen (HBsAg) loss at Week 52
Timeframe: Week 52
Percentage of participants with Hepatitis B s antigen/ antibody (HBsAg/Ab) Seroconversion at Week 52
Timeframe: Week 52
Mean alanine aminotransferase (ALT) level at Week 52
Timeframe: Week 52
Percentage of participants with alanine aminotransferase (ALT) normalization at Week 52
Timeframe: Week 52
Time to onset of ALT normalization
Timeframe: From Baseline to Week 52
Rate of Emergence of Resistant Virus at Week 52
Timeframe: Week 52
Interventions:
Drug: LAM group
Drug: ADV group
Enrollment:
105
Observational study model:
Not applicable
Primary completion date:
2008-16-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Chronic Hepatitis B
Product
adefovir
Collaborators
Not applicable
Study date(s)
January 2006 to January 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
16 - 64 years
Accepts healthy volunteers
No
- Have compensated chronic hepatitis B.
- Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
- Having or suspected of having liver cancer.
- Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
Inclusion and exclusion criteria
Inclusion criteria:
- Have compensated chronic hepatitis B.
- Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
- Ability to read, understand, and sign the informed consent.
- Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L
Exclusion criteria:
- Having or suspected of having liver cancer.
- Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
- Autoimmune hepatitis.
- Received any previous transplantation or having a plan for any transplantation.
- Existence of any serious complication, except hepatitis B.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-16-01
Actual study completion date
2008-16-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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