Health Condition 1: null- CHILDREN WITH HBEAG-POSITIVE CHRONIC HEPATITIS B IN THE IMMUNE-TOLERANT PHASE
Conditions
Interventions
Intervention1: PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH Lamivudine or Entecavir: Treated patients will receive lamivudine as a film-coated tablet or oral solution once daily at a dose of 3 mg/
Sponsors
F HoffmannLa Roche Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients 3â??17 years of age at baseline (or 12 â??17 years of age at baseline in Russia) 2. Positive for HBsAg and HBeAg for more than 6 months prior to baseline 3. Detectable HBV-DNA ( > 10,000 copies/mL [ > 2000 IU/mL]) (as measured by polymerization chain reaction [PCR] or hybridization) on at least 2 occasions one month apart with at least one of the determinations obtained 4. Compensated liver disease (Child-Pugh Class A clinical classification)
Exclusion criteria
Exclusion criteria: 1. Patients who have received investigational drugs or licensed treatments with anti HBV activity (e.g., interferons [IFNs], lamivudine, tenofovir, emtricitabine, adefovir, entecavir, telbivudine, systemic acyclovir, systemic famciclovir) (Exception: Patients who have had a limited [ 2. Patients who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline 3. Known hypersensitivity to IFN, Pegasys or lamivudine 4. History of immunologically mediated disease to include, but not limited to: autoimmune hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or clinical evidence of rheumatoid arthritis 5. History of solid organ or bone marrow transplantation 6. History or other evidence of severe retinopathy 7. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study 8. Active substance abuse within 6 months prior to screening 9. Sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment 10. Females who are pregnant or who are breastfeeding. (Females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome measure for this study is Safety at 24 weeks post treatment/end of untreated observationTimepoint: The primary efficacy outcome measure for this study is Safety at 24 weeks post treatment/end of untreated observation | — |
Secondary
| Measure | Time frame |
|---|---|
| Safey & EfficacyTimepoint: The secondary efficacy outcome measures for this study at 1, 2, 3, 4, and 5 years post end of treatment | — |
Countries
Dominican Republic, Egypt, Germany, Guatemala, India, Romania, Russian Federation, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Aditi Parekh
Roche Products India Pvt. Ltd.
Outcome results
None listed