ID

35974

Beschreibung

An Open-Label, Multicenter, National Observational Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS (Peginterferon Alfa-2a 40kD) - The PRO B Study; ODM derived from: https://clinicaltrials.gov/show/NCT02201407

Link

https://clinicaltrials.gov/show/NCT02201407

Stichworte

Versionen (1)
  1. 08.04.19 08.04.19 -
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See clinicaltrials.gov

Hochgeladen am

8. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02201407

Englisch

Eligibility Hepatitis B, Chronic NCT02201407

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients >/= 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hepatitis b virus e antigen (hbeag) positive or hbeag negative serologically proven chronic hepatitis b (chb) with or without cirrhosis (histologically verified at some point in the past)
Beschreibung

Chronic Hepatitis B HBeAg positive Serology | Chronic Hepatitis B HBeAg Serology negative | Liver Cirrhosis | Liver Cirrhosis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0392390
UMLS CUI [1,3]
C0036743
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0019167
UMLS CUI [2,3]
C0919674
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0332197
baseline hepatitis b virus (hbv) dna >2,000 iu/ml
Beschreibung

Hepatitis B DNA Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C3641250
elevated serum alanine aminotransferase (alt) > upper limit of normal (uln)
Beschreibung

Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
patients treated with previous nucleos(t)ide analogs (nas) therapy are eligible for this study
Beschreibung

Nucleoside Analogs | Nucleotide analog

Datentyp

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have contraindications for peginterferon alfa-2a (pegasys®) in accordance with the approved summary of product characteristics (e.g., severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
Beschreibung

Medical contraindication Peginterferon alfa-2a | Medical contraindication Pegasys | Mental Disorders, Severe | Immune System Disease | Liver Dysfunction Severe | Decompensated cirrhosis of liver | Retinal Disease Severe | Thyroid dysfunction Severe | Hepatitis, Autoimmune | Heart Disease Severe Pre-existing | Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon-alpha | Hypersensitivity Interferon-alpha Pharmaceutical Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0391001
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1176430
UMLS CUI [3]
C4046029
UMLS CUI [4]
C0021053
UMLS CUI [5,1]
C0086565
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C1619727
UMLS CUI [7,1]
C0035309
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0348024
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C0241910
UMLS CUI [10,1]
C0018799
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C2347662
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0013230
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0002199
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C0002199
UMLS CUI [13,3]
C0015237
patients with alt > 10 x uln or evidence of hepatocellular carcinoma
Beschreibung

Alanine aminotransferase increased | Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C2239176
patients with serological evidence of co-infection with hepatitis a virus, hepatitis c, human immunodeficiency virus or hepatitis d virus
Beschreibung

Coinfection Hepatitis A Virus Serology | HCV coinfection Serology | HIV coinfection Serology | Coinfection Hepatitis Delta Virus Serology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0376325
UMLS CUI [1,3]
C0036743
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C0036743
UMLS CUI [3,1]
C4062778
UMLS CUI [3,2]
C0036743
UMLS CUI [4,1]
C0275524
UMLS CUI [4,2]
C0011220
UMLS CUI [4,3]
C0036743
patients with decompensated liver disease
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
pregnant or breast-feeding women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of liver transplantation or planned for liver transplantation
Beschreibung

Transplantation of liver | Transplantation of liver Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2,1]
C0023911
UMLS CUI [2,2]
C1301732
concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contraindicated according to telbivudine label)
Beschreibung

telbivudine | Peginterferon alfa-2a Contraindicated

Datentyp

boolean

Alias
UMLS CUI [1]
C1453933
UMLS CUI [2,1]
C0391001
UMLS CUI [2,2]
C1444657
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Ähnliche Modelle

Eligibility Hepatitis B, Chronic NCT02201407

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis B HBeAg positive Serology | Chronic Hepatitis B HBeAg Serology negative | Liver Cirrhosis | Liver Cirrhosis Absent
Item
hepatitis b virus e antigen (hbeag) positive or hbeag negative serologically proven chronic hepatitis b (chb) with or without cirrhosis (histologically verified at some point in the past)
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C0524909 (UMLS CUI [2,1])
C0019167 (UMLS CUI [2,2])
C0919674 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hepatitis B DNA Measurement
Item
baseline hepatitis b virus (hbv) dna >2,000 iu/ml
boolean
C3641250 (UMLS CUI [1])
Alanine aminotransferase increased
Item
elevated serum alanine aminotransferase (alt) > upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Nucleoside Analogs | Nucleotide analog
Item
patients treated with previous nucleos(t)ide analogs (nas) therapy are eligible for this study
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Peginterferon alfa-2a | Medical contraindication Pegasys | Mental Disorders, Severe | Immune System Disease | Liver Dysfunction Severe | Decompensated cirrhosis of liver | Retinal Disease Severe | Thyroid dysfunction Severe | Hepatitis, Autoimmune | Heart Disease Severe Pre-existing | Hypersensitivity Investigational New Drugs | Hypersensitivity Interferon-alpha | Hypersensitivity Interferon-alpha Pharmaceutical Excipient
Item
patients who have contraindications for peginterferon alfa-2a (pegasys®) in accordance with the approved summary of product characteristics (e.g., severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
boolean
C1301624 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1176430 (UMLS CUI [2,2])
C4046029 (UMLS CUI [3])
C0021053 (UMLS CUI [4])
C0086565 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C1619727 (UMLS CUI [6])
C0035309 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0348024 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0241910 (UMLS CUI [9])
C0018799 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C2347662 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C0013230 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12,1])
C0002199 (UMLS CUI [12,2])
C0020517 (UMLS CUI [13,1])
C0002199 (UMLS CUI [13,2])
C0015237 (UMLS CUI [13,3])
Alanine aminotransferase increased | Liver carcinoma
Item
patients with alt > 10 x uln or evidence of hepatocellular carcinoma
boolean
C0151905 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
Coinfection Hepatitis A Virus Serology | HCV coinfection Serology | HIV coinfection Serology | Coinfection Hepatitis Delta Virus Serology
Item
patients with serological evidence of co-infection with hepatitis a virus, hepatitis c, human immunodeficiency virus or hepatitis d virus
boolean
C0275524 (UMLS CUI [1,1])
C0376325 (UMLS CUI [1,2])
C0036743 (UMLS CUI [1,3])
C1698259 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0275524 (UMLS CUI [4,1])
C0011220 (UMLS CUI [4,2])
C0036743 (UMLS CUI [4,3])
Decompensated liver disease
Item
patients with decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Transplantation of liver | Transplantation of liver Planned
Item
a history of liver transplantation or planned for liver transplantation
boolean
C0023911 (UMLS CUI [1])
C0023911 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
telbivudine | Peginterferon alfa-2a Contraindicated
Item
concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contraindicated according to telbivudine label)
boolean
C1453933 (UMLS CUI [1])
C0391001 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
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