ID

44358

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01519960

Stichworte

Versionen (2)
  1. 29.01.20 29.01.20 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01519960

Englisch

Eligibility Hepatitis B, Chronic NCT01519960

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients, 3 years to <18 years of age at baseline
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
positive hbsag for more than 6 months
Beschreibung

Hepatitis B surface antigen positive Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149709
UMLS CUI [1,2]
C0449238
positive hbeag and detectable hbv dna at screening
Beschreibung

Hepatitis B e antigen positive | Hepatitis B DNA detectable

Datentyp

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C1096264
negative anti-hbs and anti-hbe at screening
Beschreibung

Hepatitis B surface antibody negative | Anti-HBe antibody negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0744842
UMLS CUI [2]
C0948253
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
Beschreibung

Fibrosis Advanced Biopsy of liver | Liver Cirrhosis Excluded Biopsy of liver | Status post Therapy Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016059
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0019163
compensated liver disease (child-pugh class a)
Beschreibung

Compensated liver disease Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
elevated serum alanine transferase (alt)
Beschreibung

Elevated serum alanine aminotransferase (ALT)

Datentyp

boolean

Alias
UMLS CUI [1]
C4313265
normal thyroid gland function at screening
Beschreibung

Thyroid Function

Datentyp

boolean

Alias
UMLS CUI [1]
C0040130
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with cirrhosis
Beschreibung

Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
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
Beschreibung

Investigational New Drugs | Anti-hepatitis B (HBV) Agents | Patient need for Antiviral Therapy Systemic | Exception Therapy Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C4020577
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0280274
UMLS CUI [3,3]
C0205373
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C2348563
known hypersensitivity to peginterferon
Beschreibung

Hypersensitivity PEGINTERFERON

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0982327
positive test results at screening for hepatitis a, hepatitis c, hepatitis d or hiv infection
Beschreibung

Hepatitis A test positive | Hepatitis C test positive | Hepatitis D virus test positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0560226
UMLS CUI [2]
C1609517
UMLS CUI [3]
C2938956
UMLS CUI [4]
C0019699
history or evidence of medical condition associated with chronic liver disease other than chronic hepatitis b
Beschreibung

Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524909
history or evidence of bleeding from esophageal varices
Beschreibung

Bleeding esophageal varices

Datentyp

boolean

Alias
UMLS CUI [1]
C0155789
decompensated liver disease (e.g. ascites, child-pugh class b or c)
Beschreibung

Decompensated liver disease | Ascites | Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C4050412
history of immunologically mediated disease
Beschreibung

Disease Immune-mediated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4330477
pregnant or lactating females
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Hepatitis B, Chronic NCT01519960

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh class a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (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])
Item Group
C0680251 (UMLS CUI)
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])
Hypersensitivity PEGINTERFERON
Item
known hypersensitivity to peginterferon
boolean
C0020517 (UMLS CUI [1,1])
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])
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])
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])
C4050412 (UMLS CUI [3])
Disease Immune-mediated
Item
history of immunologically mediated disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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