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Information:
Fel:
ID
39563
Beskrivning
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01519960
Länk
https://clinicaltrials.gov/show/NCT01519960
Nyckelord
Versioner (2)
- 2020-01-29 2020-01-29 -
- 2021-09-20 2021-09-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
29 januari 2020
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01519960
Eligibility Hepatitis B, Chronic NCT01519960
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B, Chronic NCT01519960
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
male or female patients, 3 years to <18 years of age at baseline
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive Duration
Item
positive hbsag for more than 6 months
boolean
C0149709 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Hepatitis B e antigen positive | Hepatitis B DNA detectable
Item
positive hbeag and detectable hbv dna at screening
boolean
C0392390 (UMLS CUI [1])
C1096264 (UMLS CUI [2])
C1096264 (UMLS CUI [2])
Hepatitis B surface antibody negative | Anti-HBe antibody negative
Item
negative anti-hbs and anti-hbe at screening
boolean
C0744842 (UMLS CUI [1])
C0948253 (UMLS CUI [2])
C0948253 (UMLS CUI [2])
Fibrosis Advanced Biopsy of liver | Liver Cirrhosis Excluded Biopsy of liver | Status post Therapy Hepatitis B
Item
a liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis b) to confirm the presence of advanced fibrosis or exclude cirrhosis
boolean
C0016059 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0019163 (UMLS CUI [3,3])
C0205179 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0019163 (UMLS CUI [3,3])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh class a)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C2347612 (UMLS CUI [1,2])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alanine transferase (alt)
boolean
C4313265 (UMLS CUI [1])
Thyroid Function
Item
normal thyroid gland function at screening
boolean
C0040130 (UMLS CUI [1])
Liver Cirrhosis
Item
subjects with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Investigational New Drugs | Anti-hepatitis B (HBV) Agents | Patient need for Antiviral Therapy Systemic | Exception Therapy Study Protocol
Item
subjects must not have received investigational drugs or licensed treatments with anti-hbv activity within 6 months of baseline. subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded
boolean
C0013230 (UMLS CUI [1])
C4020577 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0280274 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
C4020577 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0280274 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Hypersensitivity PEGINTERFERON
Item
known hypersensitivity to peginterferon
boolean
C0020517 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C0982327 (UMLS CUI [1,2])
Hepatitis A test positive | Hepatitis C test positive | Hepatitis D virus test positive | HIV Seropositivity
Item
positive test results at screening for hepatitis a, hepatitis c, hepatitis d or hiv infection
boolean
C0560226 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C2938956 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
C1609517 (UMLS CUI [2])
C2938956 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis B
Item
history or evidence of medical condition associated with chronic liver disease other than chronic hepatitis b
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524909 (UMLS CUI [2,2])
Bleeding esophageal varices
Item
history or evidence of bleeding from esophageal varices
boolean
C0155789 (UMLS CUI [1])
Decompensated liver disease | Ascites | Child-Pugh Classification
Item
decompensated liver disease (e.g. ascites, child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C2347612 (UMLS CUI [3])
C0003962 (UMLS CUI [2])
C2347612 (UMLS CUI [3])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
C4330477 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])