Chronic Hepatitis B
Conditions
Interventions
Trade Name: Hepsera
Product Name: Hepsera
Pharmaceutical Form: Tablet
INN or Proposed INN: Adefovir Dipivoxil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Ph
Sponsors
Gilead Sciences Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged 2 to 3 g/dL (> 30 g/L). • Total bilirubin =
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will be excluded from enrollment into this study: • Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include any active clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, or malignancy. • Received immunoglobulins or other immune or cytokine based therapies with possible activity against hepatitis B disease within 6 months prior to the initial screening visit. • Received interferon therapy within 6 months prior to the initial screening visit. • Received lamivudine therapy within 6 months prior to the initial screening visit. • Received previous treatment with antiviral agents demonstrating anti HBV activity other than interferon or lamivudine within 6 months prior to the initial screening visit (e.g., famciclovir, lobucavir, ganciclovir, emtricitabine, amdoxovir, clevudine, entecavir, or others). • Previous or current therapy with adefovir dipivoxil except for those patients who participated in study GS 02 517. • Participation in an investigational trial involving administration of any investigational compound within 2 months prior to the initial screening visit. • Organ or bone marrow transplant recipients. • Evidence of steatosis or active liver disease due to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, or hepatitis D co infection). • Clinical evidence of decompensated liver disease in the opinion of the investigator. (A liver biopsy is not required to rule out cirrhosis.) • Patients with a Child Pugh Turcotte score > 6. • Clinically relevant alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events. • Received systemic (i.e., oral or intravenous) steroids, immunosuppressant therapies or chemotherapeutic agents within 2 months prior to the initial screening visit or is expected to receive these agents during the course of the study. • Received nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis platinum, pentamidine, tacrolimus, cyclosporine) or competitors of renal excretion (e.g., probenecid) within 2 months prior to the initial screening visit or is expected to receive these agents during the course of the study. • Received hepatotoxic drugs (e.g., anabolic steroids, ketaconazole, itraconazole, isoniazid, rifampin, rifabutin, simvistatin, lovastatin) within 2 months prior to the initial screening visit or is expected to receive these during the course of the study. • Received tenofovir disoproxil fumarate (Viread®) within 6 months prior to the initial screening visit. • History of hypersensitivity to any nucleoside and/or nucleotide analogues. • Clinical, ultrasonographic, or radiologic evidence of hepatic mass suggestive of hepatocellular carcinoma. • Lactating females or females with a positive serum pregnancy test. • Inability to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to ULN at baseline. ;Secondary Objective: To investigate the safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to < 18) compared to placebo following 48 weeks of treatment. To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of treatment with adefovir dipivoxil or placebo. To evaluate the development of HBV mutants resistant to adefovir dipivoxil. To evaluate the long-term safety and efficacy in children and adolescents over an additional 4 year follow up period including assessment of growth and renal function. | — |
Countries
Spain
Outcome results
None listed