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Eligibility Chronic Hepatitis B NCT01401400

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of chronic hepatitis b, defined as the presence of positive hepatitis b surface antigen (hbsag) for at least 6 months.
Description

Hepatitis B, Chronic | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
history of treatment (per protocol or outside studies) with standard interferon (alfa-2a or alfa-2b), peginterferon alfa-2a or peginterferon alfa-2b for at least 12 weeks.
Description

Interferon therapy Standard | Interferon Alfa-2a | Interferon Alfa-2b | peginterferon alfa-2a | peginterferon alfa-2b

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C1442989
UMLS CUI [2]
C0021734
UMLS CUI [3]
C0021735
UMLS CUI [4]
C0391001
UMLS CUI [5]
C0796545
a follow-up duration of at least 24 weeks after the last dose of (peg)interferon.
Description

Follow-up Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0449238
use of nucleos(t)ide analogues prior to or combined with (peg)interferon treatment is allowed.
Description

Nucleoside Analogs | Nucleotide analog | Interferon therapy | Peginterferon | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
UMLS CUI [3]
C0279030
UMLS CUI [4]
C0982327
UMLS CUI [5]
C0009429
available hbv dna and hbeag status at baseline, end of treatment and end of follow-up (24 weeks after end of treatment)
Description

Hbv DNA Test | Hepatitis Be antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C1256114
UMLS CUI [2]
C0201483
written informed consent obtained.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infection with hepatitis c virus, delta virus or human immunodeficiency virus.
Description

HCV coinfection | Coinfection Hepatitis Delta Virus | HIV Coinfection

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4505456
use of immunosuppressants, chemotherapy or systemic corticosteroids (prednisolone 30 mg daily or equivalent for more than 7 days) during (peg)interferon treatment or the 24-week pre- and post-treatment period.
Description

Immunosuppressive Agents | Chemotherapy | CORTICOSTEROIDS FOR SYSTEMIC USE | Prednisolone U/day | Prednisolone Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0392920
UMLS CUI [3]
C3653708
UMLS CUI [4,1]
C0032950
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0032950
UMLS CUI [5,2]
C0205163
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Similar models

Eligibility Chronic Hepatitis B NCT01401400

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Hepatitis B surface antigen positive
Item
history of chronic hepatitis b, defined as the presence of positive hepatitis b surface antigen (hbsag) for at least 6 months.
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Interferon therapy Standard | Interferon Alfa-2a | Interferon Alfa-2b | peginterferon alfa-2a | peginterferon alfa-2b
Item
history of treatment (per protocol or outside studies) with standard interferon (alfa-2a or alfa-2b), peginterferon alfa-2a or peginterferon alfa-2b for at least 12 weeks.
boolean
C0279030 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0021734 (UMLS CUI [2])
C0021735 (UMLS CUI [3])
C0391001 (UMLS CUI [4])
C0796545 (UMLS CUI [5])
Follow-up Duration
Item
a follow-up duration of at least 24 weeks after the last dose of (peg)interferon.
boolean
C3274571 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Nucleoside Analogs | Nucleotide analog | Interferon therapy | Peginterferon | Combined Modality Therapy
Item
use of nucleos(t)ide analogues prior to or combined with (peg)interferon treatment is allowed.
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
C0279030 (UMLS CUI [3])
C0982327 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
Hbv DNA Test | Hepatitis Be antigen measurement
Item
available hbv dna and hbeag status at baseline, end of treatment and end of follow-up (24 weeks after end of treatment)
boolean
C1256114 (UMLS CUI [1])
C0201483 (UMLS CUI [2])
Informed Consent
Item
written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HCV coinfection | Coinfection Hepatitis Delta Virus | HIV Coinfection
Item
co-infection with hepatitis c virus, delta virus or human immunodeficiency virus.
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4505456 (UMLS CUI [3])
Immunosuppressive Agents | Chemotherapy | CORTICOSTEROIDS FOR SYSTEMIC USE | Prednisolone U/day | Prednisolone Equivalent
Item
use of immunosuppressants, chemotherapy or systemic corticosteroids (prednisolone 30 mg daily or equivalent for more than 7 days) during (peg)interferon treatment or the 24-week pre- and post-treatment period.
boolean
C0021081 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C3653708 (UMLS CUI [3])
C0032950 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0032950 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
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