Evidence of decompensated liver disease (Childs B-C), hepato-cellular carcinoma, pre-existing severe depression or other psychiatric disease, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy.
received telbivudine as the antiviral therapy or have received more than one NA in the past.
received interferon or peginterferon treatment in the past.
received antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment (including supraphysiologic doses of steroids and radiation) within the past 6 months.
Positive test at screening for anti-HIV, anti-HCV.
Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited (<=7 days) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
Serum total bilirubin > 3 times the upper limit of normal at screening.
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia).
Women with ongoing pregnancy or who are breast feeding.
Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening.
Hemoglobin < 11.5 g/dL for females and < 12.5 g/dL for men at screening.
Serum creatinine level >120 umol/ml for men and >105 umol/ml for women at screening.
History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis, a period of treatment with an antidepressant medication or major tranquilizer at therapeutic doses for depression or psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease.
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
History or other evidence of chronic pulmonary disease associated with functional limitation. Severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
History of a severe seizure disorder or current anticonvulsant use.
Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >=20% within 2 years. Patients with a lesion suspicious of hepatic malignancy on a screening imaging study will only be eligible if the likelihood of carcinoma is <=10% following an appropriate evaluation.
History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
Major organ transplantation.
Thyroid disease with thyroid function poorly controlled on prescribed medications. Patients with abnormal thyroid stimulating hormone or T4 concentrations, with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
History or other evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
Inability or unwillingness to provide informed consent or abide by the requirements of the study.
History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
Evidence of drug and/or alcohol abuse (20g/day for women & 30g/day for men).
Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening
Any known history of hypersensitivity to interferon.

NCT02068365_exc_T1
Qualifier
decompensated
NCT02068365_exc_T2
Condition
liver disease
NCT02068365_exc_T3
Measurement
Childs
NCT02068365_exc_T4
Value
B-C
NCT02068365_exc_T5
Scope
decompensated liver disease
NCT02068365_exc_T6
Scope
Childs B-C
NCT02068365_exc_T7
Condition
hepato-cellular carcinoma
NCT02068365_exc_T8
Temporal
pre-existing
NCT02068365_exc_T9
Qualifier
severe
NCT02068365_exc_T10
Condition
depression
NCT02068365_exc_T11
Condition
psychiatric disease
NCT02068365_exc_T12
Qualifier
other
NCT02068365_exc_T13
Condition
cardiac disease
NCT02068365_exc_T14
Qualifier
significant
NCT02068365_exc_T15
Qualifier
significant
NCT02068365_exc_T16
Condition
renal disease
NCT02068365_exc_T17
Condition
seizure disorders
NCT02068365_exc_T18
Qualifier
severe
NCT02068365_exc_T19
Condition
retinopathy
NCT02068365_exc_T20
Scope
severe depression or other psychiatric disease
NCT02068365_exc_T21
Drug
telbivudine
NCT02068365_exc_T22
Procedure
antiviral therapy
NCT02068365_exc_T23
Multiplier
more than one
NCT02068365_exc_T24
Condition
NA
NCT02068365_exc_T25
Temporal
in the past
NCT02068365_exc_T26
Drug
interferon
NCT02068365_exc_T27
Drug
peginterferon
NCT02068365_exc_T28
Procedure
treatment
NCT02068365_exc_T29
Temporal
in the past
NCT02068365_exc_T30
Scope
interferon or peginterferon
NCT02068365_exc_T31
Procedure
antiviral therapy
NCT02068365_exc_T32
Drug
systemic anti-viral
NCT02068365_exc_T33
Procedure
i-neoplastic or atment (i
NCT02068365_exc_T34
Procedure
immuno-modulatory treatment
NCT02068365_exc_T35
Multiplier
supraphysiologic doses
NCT02068365_exc_T36
Drug
steroids
NCT02068365_exc_T37
Procedure
radiation
NCT02068365_exc_T38
Scope
supraphysiologic doses of steroids and radiation
NCT02068365_exc_T39
Scope
antiviral therapy for any systemic anti-viral, anti-neoplastic or immuno-modulatory treatment
NCT02068365_exc_T40
Temporal
within the past 6 months
NCT02068365_exc_T41
Value
Positive
NCT02068365_exc_T42
Measurement
 a anti-HIV, an
NCT02068365_exc_T43
Measurement
 a ant -HCV.
Pa
NCT02068365_exc_T44
Temporal
at screening
NCT02068365_exc_T45
Scope
 a anti-HIV, anti-HCV.
Pa
NCT02068365_exc_T46
Mood
expected to need
NCT02068365_exc_T47
Procedure
systemic antiviral therapy
NCT02068365_exc_T48
Temporal
at any time during their participation in the study
NCT02068365_exc_T49
Reference_point
their participation in the study
NCT02068365_exc_T50
Drug
acyclovir
NCT02068365_exc_T51
Multiplier
ed (<=7 e of a
NCT02068365_exc_T52
Multiplier
<=7 days
NCT02068365_exc_T53
Condition
herpetic lesions
NCT02068365_exc_T54
Temporal
more than 1 month prior to the first administration of test drug
NCT02068365_exc_T55
Reference_point
the first administration of test drug
NCT02068365_exc_T56
Mood
not excluded
NCT02068365_exc_T57
Negation
Exception
NCT02068365_exc_T58
Measurement
Serum total bilirubin
NCT02068365_exc_T59
Value
> 3 times the upper limit of normal
NCT02068365_exc_T60
Temporal
at screening
NCT02068365_exc_T61
Condition
bleeding
NCT02068365_exc_T62
Condition
esophageal varices
NCT02068365_exc_T63
Qualifier
other
NCT02068365_exc_T64
Condition
conditions consistent with decompensated liver disease
NCT02068365_exc_T65
Condition
medical condition
NCT02068365_exc_T66
Condition
chronic liver disease
NCT02068365_exc_T67
Negation
other than
NCT02068365_exc_T68
Condition
HBV
NCT02068365_exc_T69
Scope
other than HBV
NCT02068365_exc_T70
Condition
hemochromatosis
NCT02068365_exc_T71
Condition
autoimmune hepatitis
NCT02068365_exc_T72
Condition
metabolic liver diseases
NCT02068365_exc_T73
Condition
Wilson's
NCT02068365_exc_T74
Condition
alpha1-antitrypsin deficiency
NCT02068365_exc_T75
Condition
alcoholic liver disease
NCT02068365_exc_T76
Condition
toxin exposures
NCT02068365_exc_T77
Condition
thalassemia
NCT02068365_exc_T78
Scope
Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia
NCT02068365_exc_T79
Scope
hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia
NCT02068365_exc_T80
Person
Women
NCT02068365_exc_T81
Condition
pregnancy
NCT02068365_exc_T82
Temporal
ongoing
NCT02068365_exc_T83
Observation
breast feeding
NCT02068365_exc_T84
Measurement
Neutrophil count
NCT02068365_exc_T85
Value
<1500 cells/mm3
NCT02068365_exc_T86
Measurement
platelet count
NCT02068365_exc_T87
Value
<90,000 cells/mm3
NCT02068365_exc_T88
Temporal
at screening
NCT02068365_exc_T89
Scope
Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3
NCT02068365_exc_T90
Measurement
Hemoglobin
NCT02068365_exc_T91
Value
< 11.5 g/dL
NCT02068365_exc_T92
Person
females
NCT02068365_exc_T93
Value
< 12.5 g/dL
NCT02068365_exc_T94
Person
men
NCT02068365_exc_T95
Temporal
at screening
NCT02068365_exc_T96
Scope
< 11.5 g/dL for females and < 12.5 g/dL for men
NCT02068365_exc_T97
Measurement
Serum creatinine level
NCT02068365_exc_T98
Value
>120 umol/ml
NCT02068365_exc_T99
Person
men
NCT02068365_exc_T100
Value
>105 umol/ml
NCT02068365_exc_T101
Person
women
NCT02068365_exc_T102
Temporal
at screening
NCT02068365_exc_T103
Scope
>120 umol/ml for men and >105 umol/ml for women
NCT02068365_exc_T104
Condition
psychiatric disease
NCT02068365_exc_T105
Qualifier
severe
NCT02068365_exc_T106
Condition
depression
NCT02068365_exc_T107
Qualifier
Severe
NCT02068365_exc_T108
Condition
psychiatric disease
NCT02068365_exc_T109
Condition
major depression
NCT02068365_exc_T110
Condition
psychosis
NCT02068365_exc_T111
Procedure
treatment
NCT02068365_exc_T112
Drug
antidepressant medication
NCT02068365_exc_T113
Drug
major tranquilizer
NCT02068365_exc_T114
Multiplier
therapeutic doses
NCT02068365_exc_T115
Condition
depression
NCT02068365_exc_T116
Condition
psychosis
NCT02068365_exc_T117
Temporal
for at least 3 months
NCT02068365_exc_T118
Condition
suicidal attempt
NCT02068365_exc_T119
Procedure
hospitalization
NCT02068365_exc_T120
Condition
psychiatric disease
NCT02068365_exc_T121
Condition
disability
NCT02068365_exc_T122
Condition
psychiatric disease
NCT02068365_exc_T123
Scope
antidepressant medication or major tranquilizer
NCT02068365_exc_T124
Scope
major depression or psychosis, a period of treatment with an antidepressant medication or major tranquilizer at therapeutic doses for depression or psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
NCT02068365_exc_T125
Scope
Severe psychiatric disease
NCT02068365_exc_T126
Scope
severe psychiatric disease, especially depression
NCT02068365_exc_T127
Condition
inflammatory bowel disease
NCT02068365_exc_T128
Condition
immunologically mediated disease
NCT02068365_exc_T129
Condition
idiopathic thrombocytopenic purpura
NCT02068365_exc_T130
Condition
lupus erythematosus
NCT02068365_exc_T131
Condition
autoimmune hemolytic anemia
NCT02068365_exc_T132
Condition
scleroderma
NCT02068365_exc_T133
Qualifier
severe
NCT02068365_exc_T134
Condition
psoriasis
NCT02068365_exc_T135
Condition
rheumatoid arthritis
NCT02068365_exc_T136
Scope
inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis
NCT02068365_exc_T137
Condition
chronic pulmonary disease
NCT02068365_exc_T138
Condition
functional limitation
NCT02068365_exc_T139
Qualifier
Severe
NCT02068365_exc_T140
Condition
cardiac disease
NCT02068365_exc_T141
Measurement
NYHA
NCT02068365_exc_T142
Value
Functional Class III or IV
NCT02068365_exc_T143
Condition
myocardial infarction
NCT02068365_exc_T144
Temporal
within 6 months
NCT02068365_exc_T145
Condition
ventricular tachyarrhythmias
NCT02068365_exc_T146
Temporal
ongoing
NCT02068365_exc_T147
Procedure
treatment
NCT02068365_exc_T148
Condition
unstable angina
NCT02068365_exc_T149
Qualifier
other
NCT02068365_exc_T150
Qualifier
significant
NCT02068365_exc_T151
Condition
cardiovascular diseases
NCT02068365_exc_T152
Scope
Severe cardiac disease
NCT02068365_exc_T153
Scope
NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases
NCT02068365_exc_T154
Qualifier
severe
NCT02068365_exc_T155
Condition
seizure disorder
NCT02068365_exc_T156
Drug
anticonvulsant
NCT02068365_exc_T157
Temporal
current
NCT02068365_exc_T158
Temporal
active
NCT02068365_exc_T159
Mood
suspected
NCT02068365_exc_T160
Condition
cancer
NCT02068365_exc_T161
Scope
active or suspected
NCT02068365_exc_T162
Condition
malignancy
NCT02068365_exc_T163
Measurement
risk of recurrence
NCT02068365_exc_T164
Value
>=20% within 2 years
NCT02068365_exc_T165
Condition
lesion
NCT02068365_exc_T166
Mood
suspicious
NCT02068365_exc_T167
Condition
hepatic malignancy
NCT02068365_exc_T168
Procedure
screening imaging study
NCT02068365_exc_T169
Measurement
likelihood of carcinoma
NCT02068365_exc_T170
Value
<=10%
NCT02068365_exc_T171
Scope
lesion suspicious of hepatic malignancy on a screening imaging study
NCT02068365_exc_T172
Qualifier
systemic
NCT02068365_exc_T173
Procedure
ncluding radiat ng system
NCT02068365_exc_T174
Procedure
immunomodulatory treatment
NCT02068365_exc_T175
Procedure
radiation
NCT02068365_exc_T176
Qualifier
systemic
NCT02068365_exc_T177
Drug
corticosteroids
NCT02068365_exc_T178
Scope
anti-neoplastic (including radiation) or immunomodulatory treatment (including systemic corticosteroids)
NCT02068365_exc_T179
Temporal
<=6 months prior to the first dose of study drug
NCT02068365_exc_T180
Reference_point
the first dose of study drug
NCT02068365_exc_T181
Mood
expectation
NCT02068365_exc_T182
Procedure
treatment
NCT02068365_exc_T183
Mood
will be needed
NCT02068365_exc_T184
Temporal
at any time during the study
NCT02068365_exc_T185
Procedure
Major organ transplantation
NCT02068365_exc_T186
Condition
Thyroid disease
NCT02068365_exc_T187
Measurement
thyroid function
NCT02068365_exc_T188
Value
poorly controlled
NCT02068365_exc_T189
Qualifier
on prescribed medications
NCT02068365_exc_T190
Value
abnormal
NCT02068365_exc_T191
Measurement
thyroid stimulating hormone
NCT02068365_exc_T192
Measurement
T4 concentrations
NCT02068365_exc_T193
Scope
abnormal thyroid stimulating hormone or T4 concentrations
NCT02068365_exc_T194
Scope
abnormal thyroid stimulating hormone or T4 concentrations
NCT02068365_exc_T195
Measurement
antibodies to thyroid peroxidase
NCT02068365_exc_T196
Value
elevation
NCT02068365_exc_T197
Condition
clinical manifestations of thyroid disease
NCT02068365_exc_T198
Qualifier
severe
NCT02068365_exc_T199
Condition
retinopathy
NCT02068365_exc_T200
Condition
CMV retinitis
NCT02068365_exc_T201
Condition
macula degeneration
NCT02068365_exc_T202
Scope
CMV retinitis, macula degeneration
NCT02068365_exc_T203
Scope
severe retinopathy
NCT02068365_exc_T204
Qualifier
clinically relevant
NCT02068365_exc_T205
Condition
ophthalmological disorder
NCT02068365_exc_T206
Condition
diabetes mellitus
NCT02068365_exc_T207
Condition
hypertension
NCT02068365_exc_T208
Scope
diabetes mellitus or hypertension
NCT02068365_exc_T211
Measurement
alpha-fetoprotein
NCT02068365_exc_T212
Value
>100 ng/mL
NCT02068365_exc_T213
Temporal
at least the previous 3 months
NCT02068365_exc_T214
Reference_point
the previous 3 months
NCT02068365_exc_T215
Condition
stability
NCT02068365_exc_T216
Value
less than 10%
NCT02068365_exc_T217
Measurement
increase
NCT02068365_exc_T218
Scope
less than 10% increase
NCT02068365_exc_T219
Negation
unless
NCT02068365_exc_T220
Condition
alcohol abuse
NCT02068365_exc_T221
Condition
 (2 & 30g
NCT02068365_exc_T222
Multiplier
20g/day
NCT02068365_exc_T223
Multiplier
30g/day
NCT02068365_exc_T224
Person
men
NCT02068365_exc_T225
Person
women
NCT02068365_exc_T226
Scope
20g/day for women & 30g/day for men
NCT02068365_exc_T228
Condition
hypersensitivity
NCT02068365_exc_T229
Drug
interferon