Status:
COMPLETED
An Open Label, Multi Centre Phase IV Study of Adefovir Dipivoxil in Korean Patients With Chronic Hepatitis B (CHB)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated liver disease. The se...
Eligibility Criteria
Inclusion
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Age more than 18 years
- HBV Serology Presence of HBsAg for at least 6 months Presence of HBeAg at the time of screening Positive HBV DNA plasma assay with screening value at the time of screening
- 4\. Evidence of at least one elevated serum alanine amonotransferase (ALT) levels greater than 2 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months.
- serum ALT levels greater than 2 times (inclusive) the ULN at screening visit. 5. Availability and willingness of subject to provide written informed consent.
Exclusion
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Use of immunosuppressive therapy requiring use of more than 5mg of prednisone(or equivalent) per day, immunomodulatory therapy (including interferon or thymosin ) or systemic cytotoxic agents within previous 6 months or during the study
- Previous or current lamivudine or adefovir dipivoxil therapy or antiviral therapy with agents demonstrating potential anti-HBV activity
- Clinical signs of decompensated liver disease at screening according to the protocol
- Serum creatinine over 1.5mg per dL
- Alanine aminotransferase (ALT) over 10 times ULN at screening or history of acute exacerbation leading to transient decompensation
- Serum Amylase and/or lipase over 2 times ULN
- Inadequate haematological function
- Anti-HBe or Anti-HBs positive subjects
- Hepatocellular carcinoma as evidenced by the protocol
- Documented evidence of active liver disease
- 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 or previous liver transplantation
- Receipt of any investigational drug within within 3 months prior to screening.
- Therapy with nephrotoxic drugs or competitors of renal excretion within 2 months prior to study screening or the expectation that patient will receive any of these 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.
Key Trial Info
Start Date :
December 17 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2006
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01205165
Start Date
December 17 2004
End Date
April 28 2006
Last Update
July 2 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.