ID

33806

Description

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01341743

Link

https://clinicaltrials.gov/show/NCT01341743

Keywords

Versions (1)
  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01341743

English

Eligibility Hepatitis B NCT01341743

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female aged 18-65 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
capable of understanding and signing the informed consent. willing to comply with the study requirements;
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
serum hbsag positive and alt<10uln at study screening;
Description

Hepatitis B Surface Antigens Seropositive | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0521143
UMLS CUI [2]
C0201836
patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
Description

Nucleoside Analogue Quantity | Nucleotide analog Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1579410
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0597107
UMLS CUI [2,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of viral breakthrough or genotypic resistance on previous therapy;
Description

Viral Breakthrough | Resistance Genotypic Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C4053869
UMLS CUI [2,1]
C1514892
UMLS CUI [2,2]
C0017431
UMLS CUI [2,3]
C1514463
history of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
Description

Liver function Decompensated | Sign or Symptom Decompensation | Ascites | Bleeding varices | Encephalopathy | Peritonitis Spontaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205434
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0231187
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0333106
UMLS CUI [5]
C0085584
UMLS CUI [6,1]
C0031154
UMLS CUI [6,2]
C0205359
patient has a history of hepatocellular carcinoma(hcc) or findings suggestive of possible hcc;
Description

Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C2239176
other protocol defined exclusion criteria.
Description

Exclusion Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hepatitis B NCT01341743

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female aged 18-65 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
capable of understanding and signing the informed consent. willing to comply with the study requirements;
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Hepatitis B Surface Antigens Seropositive | Alanine aminotransferase measurement
Item
serum hbsag positive and alt<10uln at study screening;
boolean
C0019168 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
Nucleoside Analogue Quantity | Nucleotide analog Quantity
Item
patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
boolean
C1579410 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0597107 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Viral Breakthrough | Resistance Genotypic Prior Therapy
Item
history of viral breakthrough or genotypic resistance on previous therapy;
boolean
C4053869 (UMLS CUI [1])
C1514892 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
Liver function Decompensated | Sign or Symptom Decompensation | Ascites | Bleeding varices | Encephalopathy | Peritonitis Spontaneous
Item
history of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
boolean
C0232741 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0231187 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0085584 (UMLS CUI [5])
C0031154 (UMLS CUI [6,1])
C0205359 (UMLS CUI [6,2])
Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma
Item
patient has a history of hepatocellular carcinoma(hcc) or findings suggestive of possible hcc;
boolean
C2239176 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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