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

GSK study ID
ADF108005
See study documents
Clinicaltrials.gov ID
NCT00403585
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-25-04
    Observational study model:
    Not applicable
    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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 137-701
    Status
    Unmapped
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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