ID

39564

Beschreibung

A Two-year Study of Telbivudine in HBeAg Negative Hepatitis; ODM derived from: https://clinicaltrials.gov/show/NCT01521975

Link

https://clinicaltrials.gov/show/NCT01521975

Stichworte

Versionen (2)
  1. 29.01.20 29.01.20 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

29. Januar 2020

DOI

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Eligibility Hepatitis B, Chronic NCT01521975

Englisch

Eligibility Hepatitis B, Chronic NCT01521975

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
detectable serum hbsag at the screening visit and at least 6 months prior
Beschreibung

Serum Hepatitis B Surface Antigens Detectable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0019168
UMLS CUI [1,3]
C3830527
hbeag negative at screening visit
Beschreibung

Hepatitis B e Antigens Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019167
UMLS CUI [1,2]
C1513916
serum hbv dna level >2,000 iu/ml at screening visit
Beschreibung

Serum Hepatitis B DNA Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C3641250
elevated serum alt≥2 ×uln and <10×uln at screening visit (excluding alt elevations due to non-hbv reasons such as drug, alcohol etc)
Beschreibung

Elevated serum alanine aminotransferase (ALT)

Datentyp

boolean

Alias
UMLS CUI [1]
C4313265
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of clinical signs/symptoms of hepatic decompensation (child-pugh grade b or c) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
Beschreibung

Sign or Symptom Hepatic decompensation | Child-Pugh Classification | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy | Primary bacterial peritonitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C1394798
UMLS CUI [2]
C2347612
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0155789
UMLS CUI [5]
C0019151
UMLS CUI [6]
C0275551
patient has a history of hepatocellular carcinoma (hcc) or suspected symptoms of hcc, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (afp)>50ng/ml.
Beschreibung

Liver carcinoma | Symptoms Suspected Liver carcinoma | Foci Suspicious Imaging studies | Serum alpha-fetoprotein (AFP) measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C4321394
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C1881134
UMLS CUI [4]
C0546833
patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
Beschreibung

Nucleosides | Nucleotides | Nucleosides Investigational | Nucleotides Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0028621
UMLS CUI [2]
C0028630
UMLS CUI [3,1]
C0028621
UMLS CUI [3,2]
C1517586
UMLS CUI [4,1]
C0028630
UMLS CUI [4,2]
C1517586
patient has received ifn or other immunomodulatory treatment within 52 weeks before screening.
Beschreibung

Interferon | Immunomodulatory therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C1963758
patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
Beschreibung

Medical condition Requirement Acyclovir | Acyclovir Systemic Frequent | Medical condition Requirement Famciclovir | Famciclovir Systemic Frequent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001367
UMLS CUI [2,1]
C0001367
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0332183
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0209227
UMLS CUI [4,1]
C0209227
UMLS CUI [4,2]
C0205373
UMLS CUI [4,3]
C0332183
patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
Beschreibung

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Frequent | Topical corticosteroids allowed | Adrenal Cortex Hormones By inhalation allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0332183
UMLS CUI [2,1]
C0304604
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0683607
patient has used hepatotoxic drugs within one month.
Beschreibung

Pharmaceutical Preparations Hepatotoxic effect

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
Beschreibung

Heavy alcohol consumption | DRUG ABUSE ILLICIT

Datentyp

boolean

Alias
UMLS CUI [1]
C2030272
UMLS CUI [2]
C0743253
use of other investigational drugs at the time of enrollment.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to any of the study drugs (telbivudine or adefovir).
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Telbivudine | Hypersensitivity Adefovir

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1453933
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0050175
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
Beschreibung

Pregnancy | Urine pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430059
UMLS CUI [3]
C0006147
patient is co-infected with hcv, hdv or hiv.
Beschreibung

HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis b (e.g., alcoholism, autoimmune hepatitis).
Beschreibung

Cause Additional Liver disease | Cause Primary Quantity | Cause Secondary Quantity | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Hepatitis, Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0019163
UMLS CUI [5]
C0001973
UMLS CUI [6]
C0241910
history of malignancy of any organ system.
Beschreibung

Malignant Neoplasm Organ system Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C1552551
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Ähnliche Modelle

Eligibility Hepatitis B, Chronic NCT01521975

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Serum Hepatitis B Surface Antigens Detectable
Item
detectable serum hbsag at the screening visit and at least 6 months prior
boolean
C0229671 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
Hepatitis B e Antigens Negative
Item
hbeag negative at screening visit
boolean
C0019167 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Serum Hepatitis B DNA Measurement
Item
serum hbv dna level >2,000 iu/ml at screening visit
boolean
C0229671 (UMLS CUI [1,1])
C3641250 (UMLS CUI [1,2])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alt≥2 ×uln and <10×uln at screening visit (excluding alt elevations due to non-hbv reasons such as drug, alcohol etc)
boolean
C4313265 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sign or Symptom Hepatic decompensation | Child-Pugh Classification | Ascites | Bleeding esophageal varices | Hepatic Encephalopathy | Primary bacterial peritonitis
Item
patient has a history of clinical signs/symptoms of hepatic decompensation (child-pugh grade b or c) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
boolean
C3540840 (UMLS CUI [1,1])
C1394798 (UMLS CUI [1,2])
C2347612 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0155789 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
C0275551 (UMLS CUI [6])
Liver carcinoma | Symptoms Suspected Liver carcinoma | Foci Suspicious Imaging studies | Serum alpha-fetoprotein (AFP) measurement
Item
patient has a history of hepatocellular carcinoma (hcc) or suspected symptoms of hcc, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (afp)>50ng/ml.
boolean
C2239176 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C4321394 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C1881134 (UMLS CUI [3,3])
C0546833 (UMLS CUI [4])
Nucleosides | Nucleotides | Nucleosides Investigational | Nucleotides Investigational
Item
patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
boolean
C0028621 (UMLS CUI [1])
C0028630 (UMLS CUI [2])
C0028621 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0028630 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Interferon | Immunomodulatory therapy
Item
patient has received ifn or other immunomodulatory treatment within 52 weeks before screening.
boolean
C0021747 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
Medical condition Requirement Acyclovir | Acyclovir Systemic Frequent | Medical condition Requirement Famciclovir | Famciclovir Systemic Frequent
Item
patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001367 (UMLS CUI [1,3])
C0001367 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0332183 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0209227 (UMLS CUI [3,3])
C0209227 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
C0332183 (UMLS CUI [4,3])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE Frequent | Topical corticosteroids allowed | Adrenal Cortex Hormones By inhalation allowed
Item
patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0332183 (UMLS CUI [1,4])
C0304604 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Pharmaceutical Preparations Hepatotoxic effect
Item
patient has used hepatotoxic drugs within one month.
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
Heavy alcohol consumption | DRUG ABUSE ILLICIT
Item
patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
boolean
C2030272 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Telbivudine | Hypersensitivity Adefovir
Item
history of hypersensitivity to any of the study drugs (telbivudine or adefovir).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1453933 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0050175 (UMLS CUI [3,2])
Pregnancy | Urine pregnancy test positive | Breast Feeding
Item
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
boolean
C0032961 (UMLS CUI [1])
C0430059 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection
Item
patient is co-infected with hcv, hdv or hiv.
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Cause Additional Liver disease | Cause Primary Quantity | Cause Secondary Quantity | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Hepatitis, Autoimmune
Item
patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis b (e.g., alcoholism, autoimmune hepatitis).
boolean
C0015127 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C0001973 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
Malignant Neoplasm Organ system Any
Item
history of malignancy of any organ system.
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
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