ID

39558

Description

A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384); ODM derived from: https://clinicaltrials.gov/show/NCT01727271

Link

https://clinicaltrials.gov/show/NCT01727271

Keywords

Versions (1)
  1. 1/28/20 1/28/20 -
Copyright Holder

See clinicaltrials.gov

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January 28, 2020

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01727271

English

Eligibility Hepatitis B NCT01727271

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b (hepatitis b surface antigen [hbsag]-positive for >6 months or evidence of chronic hepatitis b in liver biopsy)
Description

Hepatitis B, Chronic | Hepatitis B surface antigen positive Duration | Chronic Hepatitis B Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0149709
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0524909
UMLS CUI [3,2]
C0193388
elevated serum alt level
Description

Elevated serum alanine aminotransferase (ALT)

Data type

boolean

Alias
UMLS CUI [1]
C4313265
liver biopsy or a non-invasive investigation within 12 months prior to randomization with chronic hepatitis b
Description

Biopsy of liver | Investigation Non-invasive

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0205303
treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment
Description

Therapy naive | Interferon

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0021747
compensated liver disease
Description

Compensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C3839044
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component of the study products
Description

Hypersensitivity Tenofovir | Hypersensitivity Interferon Alfa-2b | Hypersensitivity Investigational New Drug Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0384228
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021735
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1705248
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
Description

HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0011220
UMLS CUI [3]
C4062778
need for prolonged or frequent use of systemic acyclovir or famciclovir
Description

Use of Acyclovir Systemic Prolonged | Use of Famciclovir Systemic Prolonged | Use of Acyclovir Systemic Frequent | Use of Famciclovir Systemic Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0001367
UMLS CUI [1,3]
C0205373
UMLS CUI [1,4]
C0439590
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0209227
UMLS CUI [2,3]
C0205373
UMLS CUI [2,4]
C0439590
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0001367
UMLS CUI [3,3]
C0205373
UMLS CUI [3,4]
C0332183
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0209227
UMLS CUI [4,3]
C0205373
UMLS CUI [4,4]
C0332183
previously received lamivudine or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog and were resistant to these drugs
Description

Resistant to Lamivudine | Resistant to Nucleoside Investigational | Resistant to Nucleotide analog Investigational | Nucleoside Against Hepatitis B Virus | Nucleotide analog Against Hepatitis B Virus

Data type

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0209738
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C0028621
UMLS CUI [2,3]
C1517586
UMLS CUI [3,1]
C0332325
UMLS CUI [3,2]
C0597107
UMLS CUI [3,3]
C1517586
UMLS CUI [4,1]
C0028621
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0019169
UMLS CUI [5,1]
C0597107
UMLS CUI [5,2]
C0521124
UMLS CUI [5,3]
C0019169
history of variceal bleeding or other gi bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, grade iii and iv esophageal varices unless banded or other clinical signs of hepatic decompensation
Description

Bleeding varices Due to Portal Hypertension | Gastrointestinal Hemorrhage Due to Portal Hypertension | Hepatic Encephalopathy | Acute spontaneous bacterial peritonitis | Esophageal Varices Grade | Sign or Symptom Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1,1]
C0333106
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0020541
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0020541
UMLS CUI [3]
C0019151
UMLS CUI [4]
C2062979
UMLS CUI [5,1]
C0014867
UMLS CUI [5,2]
C0441800
UMLS CUI [6,1]
C3540840
UMLS CUI [6,2]
C1394798
history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc
Description

Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C2239176
need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin b, and foscarnet)
Description

Patient need for Pharmaceutical Preparations Hepatotoxic effect | Dapsone | Erythromycin | Fluconazole | Ketoconazole | Rifampin | Antitubercular Agents | Patient need for Pharmaceutical Preparations Nephrotoxicity | Anti-Inflammatory Agents, Non-Steroidal | Aminoglycosides | Amphotericin B | Foscarnet

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0235378
UMLS CUI [2]
C0010980
UMLS CUI [3]
C0014806
UMLS CUI [4]
C0016277
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0035608
UMLS CUI [7]
C0003448
UMLS CUI [8,1]
C0686904
UMLS CUI [8,2]
C0013227
UMLS CUI [8,3]
C0595916
UMLS CUI [9]
C0003211
UMLS CUI [10]
C0002556
UMLS CUI [11]
C0002679
UMLS CUI [12]
C0070895
one or more additional known primary or secondary causes of liver disease, other than hepatitis b
Description

Cause Quantity Liver disease | Exception Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019163
history of clinical pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female participants of childbearing potential and male participants must be willing to use acceptable method of birth control.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
medical condition that requires frequent or prolonged use of systemic corticosteroids
Description

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE | Use of SYSTEMIC CORTICOSTEROIDS Prolonged | Use of SYSTEMIC CORTICOSTEROIDS Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C3653708
UMLS CUI [2,3]
C0439590
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C3653708
UMLS CUI [3,3]
C0332183
use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period
Description

Warfarin | Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0003280
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Similar models

Eligibility Hepatitis B NCT01727271

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Hepatitis B surface antigen positive Duration | Chronic Hepatitis B Biopsy of liver
Item
chronic hepatitis b (hepatitis b surface antigen [hbsag]-positive for >6 months or evidence of chronic hepatitis b in liver biopsy)
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0524909 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Elevated serum alanine aminotransferase (ALT)
Item
elevated serum alt level
boolean
C4313265 (UMLS CUI [1])
Biopsy of liver | Investigation Non-invasive
Item
liver biopsy or a non-invasive investigation within 12 months prior to randomization with chronic hepatitis b
boolean
C0193388 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0205303 (UMLS CUI [2,2])
Therapy naive | Interferon
Item
treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment
boolean
C0919936 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
Compensated liver disease
Item
compensated liver disease
boolean
C3839044 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Tenofovir | Hypersensitivity Interferon Alfa-2b | Hypersensitivity Investigational New Drug Component
Item
known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component of the study products
boolean
C0020517 (UMLS CUI [1,1])
C0384228 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021735 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
HCV coinfection | Coinfection Hepatitis Delta Virus | HIV coinfection
Item
co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv)
boolean
C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])
Use of Acyclovir Systemic Prolonged | Use of Famciclovir Systemic Prolonged | Use of Acyclovir Systemic Frequent | Use of Famciclovir Systemic Frequent
Item
need for prolonged or frequent use of systemic acyclovir or famciclovir
boolean
C1524063 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C0439590 (UMLS CUI [1,4])
C1524063 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0439590 (UMLS CUI [2,4])
C1524063 (UMLS CUI [3,1])
C0001367 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C0332183 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C0209227 (UMLS CUI [4,2])
C0205373 (UMLS CUI [4,3])
C0332183 (UMLS CUI [4,4])
Resistant to Lamivudine | Resistant to Nucleoside Investigational | Resistant to Nucleotide analog Investigational | Nucleoside Against Hepatitis B Virus | Nucleotide analog Against Hepatitis B Virus
Item
previously received lamivudine or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog and were resistant to these drugs
boolean
C0332325 (UMLS CUI [1,1])
C0209738 (UMLS CUI [1,2])
C0332325 (UMLS CUI [2,1])
C0028621 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C0332325 (UMLS CUI [3,1])
C0597107 (UMLS CUI [3,2])
C1517586 (UMLS CUI [3,3])
C0028621 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0019169 (UMLS CUI [4,3])
C0597107 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0019169 (UMLS CUI [5,3])
Bleeding varices Due to Portal Hypertension | Gastrointestinal Hemorrhage Due to Portal Hypertension | Hepatic Encephalopathy | Acute spontaneous bacterial peritonitis | Esophageal Varices Grade | Sign or Symptom Hepatic decompensation
Item
history of variceal bleeding or other gi bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, grade iii and iv esophageal varices unless banded or other clinical signs of hepatic decompensation
boolean
C0333106 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0020541 (UMLS CUI [1,3])
C0017181 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0020541 (UMLS CUI [2,3])
C0019151 (UMLS CUI [3])
C2062979 (UMLS CUI [4])
C0014867 (UMLS CUI [5,1])
C0441800 (UMLS CUI [5,2])
C3540840 (UMLS CUI [6,1])
C1394798 (UMLS CUI [6,2])
Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma
Item
history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc
boolean
C2239176 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Patient need for Pharmaceutical Preparations Hepatotoxic effect | Dapsone | Erythromycin | Fluconazole | Ketoconazole | Rifampin | Antitubercular Agents | Patient need for Pharmaceutical Preparations Nephrotoxicity | Anti-Inflammatory Agents, Non-Steroidal | Aminoglycosides | Amphotericin B | Foscarnet
Item
need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin b, and foscarnet)
boolean
C0686904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0235378 (UMLS CUI [1,3])
C0010980 (UMLS CUI [2])
C0014806 (UMLS CUI [3])
C0016277 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0035608 (UMLS CUI [6])
C0003448 (UMLS CUI [7])
C0686904 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
C0595916 (UMLS CUI [8,3])
C0003211 (UMLS CUI [9])
C0002556 (UMLS CUI [10])
C0002679 (UMLS CUI [11])
C0070895 (UMLS CUI [12])
Cause Quantity Liver disease | Exception Hepatitis B
Item
one or more additional known primary or secondary causes of liver disease, other than hepatitis b
boolean
C0015127 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Pancreatitis
Item
history of clinical pancreatitis
boolean
C0030305 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
female participants of childbearing potential and male participants must be willing to use acceptable method of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE | Use of SYSTEMIC CORTICOSTEROIDS Prolonged | Use of SYSTEMIC CORTICOSTEROIDS Frequent
Item
medical condition that requires frequent or prolonged use of systemic corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C3653708 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C3653708 (UMLS CUI [3,2])
C0332183 (UMLS CUI [3,3])
Warfarin | Anticoagulants
Item
use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period
boolean
C0043031 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
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