ID

39565

Description

An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues; ODM derived from: https://clinicaltrials.gov/show/NCT01794234

Link

https://clinicaltrials.gov/show/NCT01794234

Keywords

Versions (1)
  1. 1/29/20 1/29/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 29, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01794234

English

Eligibility Hepatitis B, Chronic NCT01794234

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
positive hbsag for more than 6 months before assignment to treatment with pegasys
Description

Hepatitis B surface antigen positive Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0449238
detectable hbv dna (as measured by pcr)
Description

Hepatitis B DNA detectable Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C1096264
UMLS CUI [1,2]
C0032520
hbeag positive and negative patients
Description

Hepatitis B e antigen positive | Hepatitis B e Antigens Negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2,1]
C0019167
UMLS CUI [2,2]
C1513916
patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with pegasys according to the local therapeutic standard
Description

Nucleoside Analogs | Nucleotide analog | Antiviral Therapy failed | Pegasys

Data type

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
UMLS CUI [3,1]
C0280274
UMLS CUI [3,2]
C0231175
UMLS CUI [4]
C1176430
elevated serum alanine aminotransferase (alt)
Description

Elevated serum alanine aminotransferase (ALT)

Data type

boolean

Alias
UMLS CUI [1]
C4313265
chronic hepatitis b confirmed by liver biopsy or non-invasive assessment (fibroscan), arfi, fibrotest) or by clinical evaluation
Description

Chronic Hepatitis B Biopsy of liver | Chronic Hepatitis B Fibroscan | Chronic Hepatitis B ARFI | Chronic Hepatitis B FibroTest Score Measurement | Chronic Hepatitis B Clinical Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C4522043
UMLS CUI [3,1]
C0524909
UMLS CUI [3,2]
C1955931
UMLS CUI [4,1]
C0524909
UMLS CUI [4,2]
C3642160
UMLS CUI [5,1]
C0524909
UMLS CUI [5,2]
C4084924
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to treatment with pegasys according to the summary of product characteristics
Description

Medical contraindication Pegasys

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1176430
hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
Description

Liver carcinoma | Liver Dysfunction Severe | Decompensated cirrhosis of liver

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C1619727
immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of pegasys treatment
Description

Therapeutic immunosuppression | Immunomodulatory therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0392920
planned other than pegasys antiviral treatment during pegasys therapy
Description

Other treatment Planned | Exception Pegasys Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2015819
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1176430
UMLS CUI [2,3]
C0280274
chronic liver disease other than chronic hepatitis b
Description

Chronic liver disease | Exception Chronic Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524909
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inadequate hematologic function
Description

Hematologic function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
autoimmunology disorders
Description

Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
co-infection with chronic hepatitis c or hiv
Description

Coinfection Chronic Hepatitis C | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0524910
UMLS CUI [2]
C4062778
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Similar models

Eligibility Hepatitis B, Chronic NCT01794234

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis B surface antigen positive Duration
Item
positive hbsag for more than 6 months before assignment to treatment with pegasys
boolean
C0149709 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis B DNA detectable Polymerase Chain Reaction
Item
detectable hbv dna (as measured by pcr)
boolean
C1096264 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Hepatitis B e antigen positive | Hepatitis B e Antigens Negative
Item
hbeag positive and negative patients
boolean
C0392390 (UMLS CUI [1])
C0019167 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Nucleoside Analogs | Nucleotide analog | Antiviral Therapy failed | Pegasys
Item
patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with pegasys according to the local therapeutic standard
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
C0280274 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C1176430 (UMLS CUI [4])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alanine aminotransferase (alt)
boolean
C4313265 (UMLS CUI [1])
Chronic Hepatitis B Biopsy of liver | Chronic Hepatitis B Fibroscan | Chronic Hepatitis B ARFI | Chronic Hepatitis B FibroTest Score Measurement | Chronic Hepatitis B Clinical Evaluation
Item
chronic hepatitis b confirmed by liver biopsy or non-invasive assessment (fibroscan), arfi, fibrotest) or by clinical evaluation
boolean
C0524909 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C4522043 (UMLS CUI [2,2])
C0524909 (UMLS CUI [3,1])
C1955931 (UMLS CUI [3,2])
C0524909 (UMLS CUI [4,1])
C3642160 (UMLS CUI [4,2])
C0524909 (UMLS CUI [5,1])
C4084924 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Pegasys
Item
contraindications to treatment with pegasys according to the summary of product characteristics
boolean
C1301624 (UMLS CUI [1,1])
C1176430 (UMLS CUI [1,2])
Liver carcinoma | Liver Dysfunction Severe | Decompensated cirrhosis of liver
Item
hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
boolean
C2239176 (UMLS CUI [1])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1619727 (UMLS CUI [3])
Therapeutic immunosuppression | Immunomodulatory therapy | Chemotherapy
Item
immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of pegasys treatment
boolean
C0021079 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Other treatment Planned | Exception Pegasys Antiviral Therapy
Item
planned other than pegasys antiviral treatment during pegasys therapy
boolean
C2015819 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1176430 (UMLS CUI [2,2])
C0280274 (UMLS CUI [2,3])
Chronic liver disease | Exception Chronic Hepatitis B
Item
chronic liver disease other than chronic hepatitis b
boolean
C0341439 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hematologic function Inadequate
Item
inadequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Autoimmune Diseases
Item
autoimmunology disorders
boolean
C0004364 (UMLS CUI [1])
Coinfection Chronic Hepatitis C | HIV coinfection
Item
co-infection with chronic hepatitis c or hiv
boolean
C0275524 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2])
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