ID

20912

Description

Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253; ODM derived from: https://clinicaltrials.gov/show/NCT01237496

Link

https://clinicaltrials.gov/show/NCT01237496

Keywords

  1. 3/27/17 3/27/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

March 27, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B, Chronic NCT01237496

Eligibility Hepatitis B, Chronic NCT01237496

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients 18-55 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hbeag negative hepatitis b
Description

Chronic Hepatitis B HBeAg Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0019167
UMLS CUI [1,3]
C1513916
liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
Description

Liver disease Consistent with Chronic Hepatitis | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0019189
UMLS CUI [2]
C0193388
participation in study ml18253.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
interferon-based or any systemic anti-hbv therapy </= 12 months prior to first dose of study drug
Description

Anti-hepatitis B (HBV) Agents Interferon Based | Anti-hepatitis B (HBV) Agents Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C4020577
UMLS CUI [1,2]
C3652465
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C4020577
UMLS CUI [2,2]
C0205373
antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to first dose of study drug
Description

Antiviral Therapy | Antineoplastic Agents | Immunomodulators

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C0003392
UMLS CUI [3]
C1527392
nonresponders to previous interferon therapy and resistant to lamivudine
Description

Interferon therapy Absent response to treatment | Lamivudine Is resistant to

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0438286
UMLS CUI [2,1]
C0209738
UMLS CUI [2,2]
C0332325
co-infection with hepatitis a, c or d, or with human immunodeficiency virus (hiv)
Description

HAV Coinfection | HCV coinfection | HDV Coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
UMLS CUI [4]
C4062778
hepatocellular cancer
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
compensated (child a, score 6) or decompensated liver disease (child b or c)
Description

Compensated liver disease Child-Pugh Classification | Decompensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
UMLS CUI [2,1]
C4075847
UMLS CUI [2,2]
C2347612
history or evidence of medical condition associated with chronic liver disease other than hbv
Description

Medical condition Associated with Chronic liver disease | Hepatitis B, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2]
C0524909

Similar models

Eligibility Hepatitis B, Chronic NCT01237496

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients 18-55 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis B HBeAg Negative
Item
chronic hbeag negative hepatitis b
boolean
C0524909 (UMLS CUI [1,1])
C0019167 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Liver disease Consistent with Chronic Hepatitis | Biopsy of liver
Item
liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
boolean
C0023895 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019189 (UMLS CUI [1,3])
C0193388 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in study ml18253.
boolean
C2348568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Anti-hepatitis B (HBV) Agents Interferon Based | Anti-hepatitis B (HBV) Agents Systemic
Item
interferon-based or any systemic anti-hbv therapy </= 12 months prior to first dose of study drug
boolean
C4020577 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C4020577 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Antiviral Therapy | Antineoplastic Agents | Immunomodulators
Item
antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to first dose of study drug
boolean
C0280274 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
Interferon therapy Absent response to treatment | Lamivudine Is resistant to
Item
nonresponders to previous interferon therapy and resistant to lamivudine
boolean
C0279030 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
C0209738 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
HAV Coinfection | HCV coinfection | HDV Coinfection | HIV coinfection
Item
co-infection with hepatitis a, c or d, or with human immunodeficiency virus (hiv)
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
C4062778 (UMLS CUI [4])
Liver carcinoma
Item
hepatocellular cancer
boolean
C2239176 (UMLS CUI [1])
Compensated liver disease Child-Pugh Classification | Decompensated liver disease Child-Pugh Classification
Item
compensated (child a, score 6) or decompensated liver disease (child b or c)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2,1])
C2347612 (UMLS CUI [2,2])
Medical condition Associated with Chronic liver disease | Hepatitis B, Chronic
Item
history or evidence of medical condition associated with chronic liver disease other than hbv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C0524909 (UMLS CUI [2])

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