Treatment with any investigational drug within 30 days of entry to this protocol
Current treatment with Telbivudine
Severe hepatitis activity as documented by ALT>10 x ULN
History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
Pre-existent neutropenia (neutrophils <1,500/mm3) or thrombocytopenia (platelets < 90,000/mm3)
Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)
Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
Alpha fetoprotein > 50 ng/ml
Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
Immune suppressive treatment within the previous 6 months
Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
Pregnancy, breast-feeding
Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
Substance abuse, such as alcohol (>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study

NCT01373684_exc_T2
Drug
Telbivudine
NCT01373684_exc_T3
Condition
hepatitis
NCT01373684_exc_T4
Qualifier
Severe
NCT01373684_exc_T5
Measurement
ALT
NCT01373684_exc_T6
Value
>10 x ULN
NCT01373684_exc_T7
Condition
cirrhosis
NCT01373684_exc_T8
Qualifier
decompensated
NCT01373684_exc_T9
Condition
jaundice
NCT01373684_exc_T10
Condition
cirrhosis
NCT01373684_exc_T11
Condition
ascites
NCT01373684_exc_T12
Condition
bleeding gastric
NCT01373684_exc_T13
Condition
esophageal varices
NCT01373684_exc_T14
Condition
encephalopathy
NCT01373684_exc_T15
Scope
defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy
NCT01373684_exc_T16
Condition
neutropenia
NCT01373684_exc_T17
Qualifier
Pre-existent
NCT01373684_exc_T18
Measurement
neutrophils
NCT01373684_exc_T19
Value
<1,500/mm3
NCT01373684_exc_T20
Condition
thrombocytopenia
NCT01373684_exc_T21
Measurement
platelets
NCT01373684_exc_T22
Value
< 90,000/mm3
NCT01373684_exc_T23
Qualifier
hepatitis C virus
NCT01373684_exc_T24
Qualifier
hepatitis D virus
NCT01373684_exc_T25
Qualifier
human immunodeficiency virus
NCT01373684_exc_T26
Qualifier
HIV
NCT01373684_exc_T27
Condition
Co-infection
NCT01373684_exc_T28
Scope
hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV
NCT01373684_exc_T29
Condition
liver disease
NCT01373684_exc_T30
Qualifier
inherited
NCT01373684_exc_T31
Qualifier
acquired
NCT01373684_exc_T32
Scope
acquired or inherited
NCT01373684_exc_T33
Condition
alcoholic liver disease
NCT01373684_exc_T34
Condition
obesity induced liver disease
NCT01373684_exc_T35
Condition
drug related liver disease
NCT01373684_exc_T36
Condition
auto-immune hepatitis
NCT01373684_exc_T37
Condition
hemochromatosis
NCT01373684_exc_T38
Condition
Wilson's disease
NCT01373684_exc_T39
Condition
alpha-1 antitrypsin deficiency
NCT01373684_exc_T40
Scope
alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficienc
NCT01373684_exc_T41
Measurement
Alpha fetoprotein
NCT01373684_exc_T42
Value
> 50 ng/ml
NCT01373684_exc_T43
Condition
hypothyroidism
NCT01373684_exc_T44
Condition
r hyp sm (subjec
NCT01373684_exc_T45
Drug
medication
NCT01373684_exc_T47
Procedure
Immune suppressive treatment
NCT01373684_exc_T48
Temporal
within the previous 6 months
NCT01373684_exc_T49
Condition
Contra-indications
NCT01373684_exc_T50
Drug
alfa-interferon therapy
NCT01373684_exc_T51
Condition
hypersensitivity
NCT01373684_exc_T52
Drug
interferon
NCT01373684_exc_T53
Drug
Peginterferon
NCT01373684_exc_T55
Scope
interferon or Peginterferon
NCT01373684_exc_T57
Qualifier
significant
NCT01373684_exc_T58
Condition
medical illness
NCT01373684_exc_T59
Qualifier
significant
NCT01373684_exc_T60
Condition
pulmonary dysfunction
NCT01373684_exc_T61
Temporal
in the previous 6 months
NCT01373684_exc_T62
Condition
malignancy
NCT01373684_exc_T63
Negation
other than
NCT01373684_exc_T64
Condition
skin basocellular carcinoma
NCT01373684_exc_T65
Temporal
in previous 5 years
NCT01373684_exc_T66
Condition
immunodeficiency syndromes
NCT01373684_exc_T67
Condition
HIV positivity
NCT01373684_exc_T68
Condition
auto-immune diseases
NCT01373684_exc_T69
Procedure
organ transplants
NCT01373684_exc_T70
Negation
other than
NCT01373684_exc_T71
Procedure
air tr Any medica
NCT01373684_exc_T72
Procedure
hair transplant
NCT01373684_exc_T73
Scope
cornea and hair transplant
NCT01373684_exc_T74
Scope
organ transplants other than cornea and hair transplant
NCT01373684_exc_T75
Scope
HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant
NCT01373684_exc_T76
Scope
malignancy other than skin basocellular carcinoma in previous 5 years
NCT01373684_exc_T77
Scope
significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant
NCT01373684_exc_T78
Drug
nistrati ing the
NCT01373684_exc_T79
Qualifier
chronic
NCT01373684_exc_T80
Temporal
during the course of the study
NCT01373684_exc_T81
Reference_point
course of the study
NCT01373684_exc_T82
Condition
Substance abuse
NCT01373684_exc_T83
Qualifier
alcohol
NCT01373684_exc_T84
Qualifier
I.V. drugs
NCT01373684_exc_T85
Qualifier
inhaled drugs
NCT01373684_exc_T86
Temporal
in the past 2 years.
NCT01373684_exc_T87
Multiplier
>80 g/day
NCT01373684_exc_T88
Scope
alcohol (>80 g/day), I.V. drugs and inhaled drugs