ID

35973

Description

Study of ARC-520 in Patients With Chronic Hepatitis B Virus; ODM derived from: https://clinicaltrials.gov/show/NCT02065336

Link

https://clinicaltrials.gov/show/NCT02065336

Keywords

Versions (1)
  1. 4/8/19 4/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02065336

English

Eligibility Hepatitis B, Chronic NCT02065336

1 forms  
Criteria
Description

Criteria

have a diagnosis of hbeag negative, immune active, chronic hbv infection and all of the following:
Description

Chronic Hepatitis B HBeAg Negative | Chronic Hepatitis B Active Immune Response

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0019167
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C2936721
1. history of being hbsag positive at 2 time points > 6 months apart
Description

Hepatitis B surface antigen positive Timepoint Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1265611
2. hbsag titer > 1,000 iu/ml determined at screening
Description

Hepatitis B Surface Antigens Titer

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0475208
3. hbeag negative at screening
Description

Hepatitis B e Antigens Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C1513916
4. hbv dna < 200 iu/ml at screening
Description

Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3641250
patients with > 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness to continue taking entecavir throughout the study.
Description

Entecavir Oral Product U/day | entecavir

Data type

boolean

Alias
UMLS CUI [1,1]
C3216232
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0971023
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
female patients that have a positive pregnancy test or are lactating.
Description

Pregnancy test positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
Description

Signs Hepatitis | Signs Communicable Disease | Fever Moderate | Jaundice | Nausea | Vomiting | Abdominal Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0019158
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0009450
UMLS CUI [3,1]
C0015967
UMLS CUI [3,2]
C0205081
UMLS CUI [4]
C2010848
UMLS CUI [5]
C0027497
UMLS CUI [6]
C0042963
UMLS CUI [7]
C0000737
hepatic transaminases (alt or ast) > 100 iu/ml at screening.
Description

Transaminase Assay Hepatic | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0919834
UMLS CUI [1,2]
C0205054
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
patients with antiviral therapy other than entecavir within 3 months of screening or prior treatment with interferon or a toll receptor agonist in the last 5 years.
Description

Antiviral Therapy | Exception Entecavir | Prior interferon therapy | Toll-Like Receptor Agonist Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0971023
UMLS CUI [3]
C0278953
UMLS CUI [4]
C1883683
use within the last 6 months or an anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
Description

Anticoagulants | Adrenal Cortex Hormones | Immunomodulators | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0001617
UMLS CUI [3]
C1527392
UMLS CUI [4]
C0021081
has any history of autoimmune disease especially autoimmune hepatitis.
Description

Autoimmune Disease | Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0241910
has human immunodeficiency virus (hiv) infection, as shown by the presence of anti-hiv antibody (sero-positive).
Description

HIV Infection | Seropositive HIV antibody

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0521143
UMLS CUI [2,2]
C0019683
is sero-positive for hcv, and/or a history of delta virus hepatitis.
Description

Seropositive Hepatitis C virus | Hepatitis Delta Virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0220847
UMLS CUI [2]
C0011220
has a history of allergy to bee venom or history of hypersensitivity reaction requiring an emergency visit to a physician or hospital and/or requirement for treatment with steroids and/or epinephrine.
Description

Allergy to bee venom | Allergic Reaction Requirement Emergency visit | Allergic Reaction Requirement Emergency department patient visit | Allergic Reaction Requirement Steroids | Allergic Reaction Requirement Epinephrine

Data type

boolean

Alias
UMLS CUI [1]
C1828283
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0553618
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0586082
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0038317
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0014563
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Similar models

Eligibility Hepatitis B, Chronic NCT02065336

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Chronic Hepatitis B HBeAg Negative | Chronic Hepatitis B Active Immune Response
Item
have a diagnosis of hbeag negative, immune active, chronic hbv infection and all of the following:
boolean
C0524909 (UMLS CUI [1,1])
C0019167 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C0524909 (UMLS CUI [2,1])
C2936721 (UMLS CUI [2,2])
Hepatitis B surface antigen positive Timepoint Quantity
Item
1. history of being hbsag positive at 2 time points > 6 months apart
boolean
C0149709 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hepatitis B Surface Antigens Titer
Item
2. hbsag titer > 1,000 iu/ml determined at screening
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
Hepatitis B e Antigens Negative
Item
3. hbeag negative at screening
boolean
C0019167 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Hepatitis B DNA Measurement
Item
4. hbv dna < 200 iu/ml at screening
boolean
C3641250 (UMLS CUI [1])
Entecavir Oral Product U/day | entecavir
Item
patients with > 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness to continue taking entecavir throughout the study.
boolean
C3216232 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0971023 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pregnancy test positive | Breast Feeding
Item
female patients that have a positive pregnancy test or are lactating.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Signs Hepatitis | Signs Communicable Disease | Fever Moderate | Jaundice | Nausea | Vomiting | Abdominal Pain
Item
acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
boolean
C0311392 (UMLS CUI [1,1])
C0019158 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0015967 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C2010848 (UMLS CUI [4])
C0027497 (UMLS CUI [5])
C0042963 (UMLS CUI [6])
C0000737 (UMLS CUI [7])
Transaminase Assay Hepatic | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
hepatic transaminases (alt or ast) > 100 iu/ml at screening.
boolean
C0919834 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Antiviral Therapy | Exception Entecavir | Prior interferon therapy | Toll-Like Receptor Agonist Therapy
Item
patients with antiviral therapy other than entecavir within 3 months of screening or prior treatment with interferon or a toll receptor agonist in the last 5 years.
boolean
C0280274 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0971023 (UMLS CUI [2,2])
C0278953 (UMLS CUI [3])
C1883683 (UMLS CUI [4])
Anticoagulants | Adrenal Cortex Hormones | Immunomodulators | Immunosuppressive Agents
Item
use within the last 6 months or an anticipated requirement for anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
boolean
C0003280 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
Autoimmune Disease | Hepatitis, Autoimmune
Item
has any history of autoimmune disease especially autoimmune hepatitis.
boolean
C0004364 (UMLS CUI [1])
C0241910 (UMLS CUI [2])
HIV Infection | Seropositive HIV antibody
Item
has human immunodeficiency virus (hiv) infection, as shown by the presence of anti-hiv antibody (sero-positive).
boolean
C0019693 (UMLS CUI [1])
C0521143 (UMLS CUI [2,1])
C0019683 (UMLS CUI [2,2])
Seropositive Hepatitis C virus | Hepatitis Delta Virus
Item
is sero-positive for hcv, and/or a history of delta virus hepatitis.
boolean
C0521143 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0011220 (UMLS CUI [2])
Allergy to bee venom | Allergic Reaction Requirement Emergency visit | Allergic Reaction Requirement Emergency department patient visit | Allergic Reaction Requirement Steroids | Allergic Reaction Requirement Epinephrine
Item
has a history of allergy to bee venom or history of hypersensitivity reaction requiring an emergency visit to a physician or hospital and/or requirement for treatment with steroids and/or epinephrine.
boolean
C1828283 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0553618 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0586082 (UMLS CUI [3,3])
C1527304 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0038317 (UMLS CUI [4,3])
C1527304 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0014563 (UMLS CUI [5,3])
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