Last updated: 11/04/2018 04:32:15
Study of adefovir dipivoxil for Korean patients with chronic hepatitis B(CHB) who have completed ADF 103814
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Hepatitis B Virus (HBV) DNA (log10 copies/mL) change from Baseline at week 156 of adefovir therapy
Timeframe: Baseline, Week 156
Secondary outcomes:
Number of participants achieving ALT normalization at week 104 & 156
Timeframe: Week 104, Week 156
Number of participants achieving virological response at week 104 & 156
Timeframe: Week 104, Week 156
HBV DNA levels at each collection time point from Baseline through week 156
Timeframe: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156
Number of participants with HBeAg loss, HBeAg seroconversion, HBsAg loss and HBsAg seroconversion at week 104 & 156
Timeframe: Week 104 and 156
Safety assessment: number of participants with a serious adverse event and an adverse event
Timeframe: Treatment Phase (Weeks 53-156)
Interventions:
Drug: adefovir dipivoxil 10mg
Enrollment:
80
Observational study model:
Not applicable
Primary completion date:
2008-25-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B, Chronic
Product
adefovir
Collaborators
Not applicable
Study date(s)
July 2006 to April 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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
Inclusion and exclusion 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.
Trial location(s)
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
2008-25-04
Actual study completion date
2008-25-04
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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