Clinical trial NCT02058108 (phase 3, status: terminated)
Conditions: chronic hepatitis b
ICD codes: B18.0, B18.1, B18.2, B18.8, B18.9
Drugs: telbivudine, placebo
SMILES: CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    study terminated on the recommendation of an independent data monitoring committee (dmc)
    subsequent to an interim efficacy analysis for futility.]
  
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