Information:
Error:
ID
33487
Description
Genetic Study of Peginterferon Treatment in Hepatitis B Patients: The GIANT-B Study; ODM derived from: https://clinicaltrials.gov/show/NCT01401400
Link
https://clinicaltrials.gov/show/NCT01401400
Keywords
Versions (1)
- 12/11/18 12/11/18 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
December 11, 2018
DOI
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License
Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT01401400
Eligibility Chronic Hepatitis B NCT01401400
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Hepatitis B NCT01401400
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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])
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])
C0201483 (UMLS CUI [2])
Informed Consent
Item
written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
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])
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])
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])