Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy |
7.94; 3.89; -4.16 | <0.001 sig |
| SECONDARY Number of Participants Achieving ALT Normalization at Week 104 & 156 |
63; 65 | — |
| SECONDARY Number of Participants Achieving Virological Response at Week 104 & 156 |
20; 24 | — |
| SECONDARY HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 |
7.94; 3.90; 3.79; 3.99; 3.97; 3.88 | — |
| SECONDARY Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 |
23; 6; 0; 0; 27; 12 | — |
| SECONDARY Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event |
2; 43 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00403585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.