Informações:
Falhas:
ID
39565
Descrição
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
Palavras-chave
Versões (1)
- 29/01/2020 29/01/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
29 de janeiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01794234
Eligibility Hepatitis B, Chronic NCT01794234
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT01794234
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0006147 (UMLS CUI [2])
Hematologic function Inadequate
Item
inadequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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])
C0524910 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2])