Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis; Hepatitis, Chronic
Intervention: Telbivudine; Placebo
Intervention description: Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily; Patients of any age and weight < 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily
Intervention MeSH terms: Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Chronic hepatitis B, pediatrics, antiviral treatment, telbivudine

Summary:

      The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20
      mg/kg up to a maximum of 600 mg q.d. in compensated pediatric HBeAg-positive and negative CHB
      patients aged 2 to <18 years with the indication of antiviral CHB treatment. This study was
      part of the commitments of the pediatric development plan for telbivudine in Europe and US.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical history compatible with compensated chronic hepatitis B

          -  Documented compensated chronic hepatitis B defined by the following:

               1. Positive serum HBsAg at screening and at least one other documentation of HBsAg
                  positive at least 6 months prior to screening

               2. For HBeAg positive patients at screening, significant biologic and/or histologic
                  signs of disease activity following EASL guidelines recommendations for CHB
                  pediatric patients (serum HBV DNA level ≥ 5 log10 copies/mL (or 20 000 IU/mL)
                  (COBAS Taqman®) at screening ; serum ALT ≥ 1.5×ULN and < 10×ULN (pediatric ULN)
                  for two times during the screening period or within 6 months prior to screening

               3. For HBeAg negative patients at screening, significant biologic and/or histologic
                  signs of disease activity following EASL guidelines recommendations for CHB
                  pediatric patients (serum HBV DNA level ≥ 4 log10 copies/mL (or 2 000 IU/mL)
                  (COBAS Taqman®) at screening) ; serum ALT ≥ 1.0 ×ULN and < 10×ULN (pediatric ULN)
                  for two times during the screening period or within 12 months prior to screening)

        Key Exclusion Criteria:

          -  Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of
             HAV, HEV, CMV, EBV, or HSV.

          -  Patient has received treatment of interferon or any other immunomodulatory agents
             within the last 12 months prior to screening or any nucleoside or nucleotide drugs or
             other anti-CHB treatment (approved or investigational) at any time before screening

          -  Patient has a medical condition that requires frequent use of systemic acyclovir or
             famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic
             drugs or chemotherapy

          -  Patient has one or more additional known primary or secondary causes of liver disease,
             other than CHB; has a decompensated liver disease ; is a Liver transplant recipient or
             organ or bone marrow transplant recipient.

          -  History of any other acute or chronic medical condition (that in the opinion of the
             investigator would make the patient unsuitable for inclusion into the study.

          -  Patient has a history of myopathy, myositis, persistent muscle weakness or persistent
             high serum CK levels (≥7×ULN), any muscular disease

          -  Patient receiving any drugs potentially associated with myopathy within 3 months prior
             to screening

          -  Any other clinical significant disease, condition or abnormality, unrelated to their
             HBV infection at screening, as assessed by the investigator