ID

27925

Beschreibung

Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT; ODM derived from: https://clinicaltrials.gov/show/NCT01833611

Link

https://clinicaltrials.gov/show/NCT01833611

Stichworte

Versionen (1)
  1. 05.12.17 05.12.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Dezember 2017

DOI

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Eligibility Chronic Hepatitis NCT01833611

Englisch

Eligibility Chronic Hepatitis NCT01833611

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female subjects aged between 18 and 65 year-old with history of chronic hepatitis b virus infection;
Beschreibung

Age | Hepatitis B, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0524909
2. detectable hbsag at screening and for at least 24 weeks prior to screening or detectable hbsag for < 24 week and negative for igm core antibody and confirmation of chronic hepatitis on liver biopsy;
Beschreibung

Hepatitis B Surface Antigens Detectable | Hepatitis B core antibody IgM Negative | Chronic Hepatitis Biopsy of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C3830527
UMLS CUI [2,1]
C0373849
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0019189
UMLS CUI [3,2]
C0193388
3. alt should be within normal range in recent one year and at least twice, which are at least 3 month apart;
Beschreibung

Alanine aminotransferase normal Recently

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0855620
UMLS CUI [1,2]
C0332185
4. normal alt at screening;
Beschreibung

Alanine aminotransferase normal Screening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0855620
UMLS CUI [1,2]
C0220908
5. screening hbv dna of more than 10^5 copies/ml by roche amplicortm pcr assay performed by the central laboratory;
Beschreibung

Hepatitis B DNA assay Polymerase Chain Reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1168025
UMLS CUI [1,2]
C0032520
6. evidence of chronic hepatitis on liver biopsy (knodell hai score >= 4) performed ≤ 52 weeks prior to randomization;
Beschreibung

Chronic Hepatitis Biopsy of liver | Other Coding Score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C3846158
UMLS CUI [2,2]
C0449820
7. all women of childbearing potential must have a negative serum or urine pregnancy test.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis d virus (hdv);
Beschreibung

HIV coinfection | HCV coinfection | HDV Coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
2. other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
Beschreibung

Liver diseases | Alcoholic Liver Diseases | Autoimmune liver disease | Hepatobiliary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023896
UMLS CUI [3]
C0400936
UMLS CUI [4]
C0267792
3. patients with evidence of decompensation of liver disease;
Beschreibung

Liver disease Decompensated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205434
4. therapy with interferon, thymosin alpha or antiviral agents with activity against hepatitis b (e.g., adefovir, famciclovir, lamivudine, and telbivudine) within 24 weeks of randomization into this study;
Beschreibung

Interferon | thymalfasin | Antiviral Agents Hepatitis B | adefovir | famciclovir | Lamivudine | telbivudine

Datentyp

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0076612
UMLS CUI [3,1]
C0003451
UMLS CUI [3,2]
C0019163
UMLS CUI [4]
C0050175
UMLS CUI [5]
C0209227
UMLS CUI [6]
C0209738
UMLS CUI [7]
C1453933
5. more than 12 weeks of prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (e.g., adefovir, famciclovir lamivudine, and telbivudine);
Beschreibung

Nucleoside Analogs | Nucleotide analog | Antiviral Agents Hepatitis B | adefovir | famciclovir | Lamivudine | telbivudine

Datentyp

boolean

Alias
UMLS CUI [1]
C1579410
UMLS CUI [2]
C0597107
UMLS CUI [3,1]
C0003451
UMLS CUI [3,2]
C0019163
UMLS CUI [4]
C0050175
UMLS CUI [5]
C0209227
UMLS CUI [6]
C0209738
UMLS CUI [7]
C1453933
6. prior therapy with entecavir;
Beschreibung

entecavir

Datentyp

boolean

Alias
UMLS CUI [1]
C0971023
7. known history of allergy to nucleoside analogues;
Beschreibung

Hypersensitivity Nucleoside Analogs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1579410
8. hemoglobin < 10.0 g/dl;
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
9. platelet count < 75,000/mm3;
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
10. absolute neutrophil count< 1500 cells/mm3;
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
11. creatinine > 1.5mg/dl (133 μmol/l);
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
12. anti-nuclear antibody (ana) titer > l :160 unless attributable to non-hepatic disease.
Beschreibung

Anti-nuclear antibody measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0587178
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Ähnliche Modelle

Eligibility Chronic Hepatitis NCT01833611

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hepatitis B, Chronic
Item
1. male and female subjects aged between 18 and 65 year-old with history of chronic hepatitis b virus infection;
boolean
C0001779 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
Hepatitis B Surface Antigens Detectable | Hepatitis B core antibody IgM Negative | Chronic Hepatitis Biopsy of liver
Item
2. detectable hbsag at screening and for at least 24 weeks prior to screening or detectable hbsag for < 24 week and negative for igm core antibody and confirmation of chronic hepatitis on liver biopsy;
boolean
C0019168 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0373849 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0019189 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Alanine aminotransferase normal Recently
Item
3. alt should be within normal range in recent one year and at least twice, which are at least 3 month apart;
boolean
C0855620 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Alanine aminotransferase normal Screening
Item
4. normal alt at screening;
boolean
C0855620 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Hepatitis B DNA assay Polymerase Chain Reaction
Item
5. screening hbv dna of more than 10^5 copies/ml by roche amplicortm pcr assay performed by the central laboratory;
boolean
C1168025 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Chronic Hepatitis Biopsy of liver | Other Coding Score
Item
6. evidence of chronic hepatitis on liver biopsy (knodell hai score >= 4) performed ≤ 52 weeks prior to randomization;
boolean
C0019189 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. all women of childbearing potential must have a negative serum or urine pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HCV coinfection | HDV Coinfection
Item
1. coinfection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis d virus (hdv);
boolean
C4062778 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Liver diseases | Alcoholic Liver Diseases | Autoimmune liver disease | Hepatobiliary disease
Item
2. other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;
boolean
C0023895 (UMLS CUI [1])
C0023896 (UMLS CUI [2])
C0400936 (UMLS CUI [3])
C0267792 (UMLS CUI [4])
Liver disease Decompensated
Item
3. patients with evidence of decompensation of liver disease;
boolean
C0023895 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
Interferon | thymalfasin | Antiviral Agents Hepatitis B | adefovir | famciclovir | Lamivudine | telbivudine
Item
4. therapy with interferon, thymosin alpha or antiviral agents with activity against hepatitis b (e.g., adefovir, famciclovir, lamivudine, and telbivudine) within 24 weeks of randomization into this study;
boolean
C3652465 (UMLS CUI [1])
C0076612 (UMLS CUI [2])
C0003451 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0050175 (UMLS CUI [4])
C0209227 (UMLS CUI [5])
C0209738 (UMLS CUI [6])
C1453933 (UMLS CUI [7])
Nucleoside Analogs | Nucleotide analog | Antiviral Agents Hepatitis B | adefovir | famciclovir | Lamivudine | telbivudine
Item
5. more than 12 weeks of prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (e.g., adefovir, famciclovir lamivudine, and telbivudine);
boolean
C1579410 (UMLS CUI [1])
C0597107 (UMLS CUI [2])
C0003451 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0050175 (UMLS CUI [4])
C0209227 (UMLS CUI [5])
C0209738 (UMLS CUI [6])
C1453933 (UMLS CUI [7])
entecavir
Item
6. prior therapy with entecavir;
boolean
C0971023 (UMLS CUI [1])
Hypersensitivity Nucleoside Analogs
Item
7. known history of allergy to nucleoside analogues;
boolean
C0020517 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
Hemoglobin measurement
Item
8. hemoglobin < 10.0 g/dl;
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
9. platelet count < 75,000/mm3;
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
10. absolute neutrophil count< 1500 cells/mm3;
boolean
C0948762 (UMLS CUI [1])
Creatinine measurement, serum
Item
11. creatinine > 1.5mg/dl (133 μmol/l);
boolean
C0201976 (UMLS CUI [1])
Anti-nuclear antibody measurement
Item
12. anti-nuclear antibody (ana) titer > l :160 unless attributable to non-hepatic disease.
boolean
C0587178 (UMLS CUI [1])
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