ID

20982

Description

Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603); ODM derived from: https://clinicaltrials.gov/show/NCT00686790

Link

https://clinicaltrials.gov/show/NCT00686790

Keywords

Versions (1)
  1. 4/2/17 4/2/17 -
Uploaded on

April 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis D, Chronic NCT00686790

English

Eligibility Hepatitis D, Chronic NCT00686790

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
age 18-65 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hbsag positive >6 months.
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
alt >= 2 uln >6 months.
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
hdv rna positive serology.
Description

Hepatitis D virus RNA Seropositive

Data type

boolean

Alias
UMLS CUI [1,1]
C0486926
UMLS CUI [1,2]
C0521143
serum antibody to hepatitis delta antigen of igg and igm class.
Description

Serum antibody Hepatitis delta Antigens Immunoglobulin G | Serum antibody Hepatitis delta Antigens Immunoglobulin M

Data type

boolean

Alias
UMLS CUI [1,1]
C3833453
UMLS CUI [1,2]
C0057317
UMLS CUI [1,3]
C0020852
UMLS CUI [2,1]
C3833453
UMLS CUI [2,2]
C0057317
UMLS CUI [2,3]
C0020861
knodell score hai >= 6 and f >= 0; positive test for intrahepatic delta antigen in liver biopsy.
Description

Knodell Fibrosis Score | Hepatitis delta Antigens Positive Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1]
C3898641
UMLS CUI [2,1]
C0057317
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0193388
women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed iud, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
Description

Childbearing Potential Contraceptive methods | Postmenopausal state | Sex Behavior | Hormonal contraception | Intrauterine Devices prescribed | Female Condoms | Vaginal Spermicides | Female Sterilization | Hysterectomy | Tubal Ligation

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0036864
UMLS CUI [4]
C2985296
UMLS CUI [5,1]
C0021900
UMLS CUI [5,2]
C0278329
UMLS CUI [6]
C0221829
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0020699
UMLS CUI [10]
C0520483
participants must be free of any clinically significant disease (other than chronic hepatitis b and d), that would interfere with study evaluations.
Description

Disease Interferes with Clinical Trial Evaluation | Disease Free of | Hepatitis B, Chronic | Hepatitis D, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524911
participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
Description

Protocol Compliance | maintain symptom diary | Severity of Symptom Scale | Medication record | Adverse event Records

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C2216446
UMLS CUI [3]
C3897633
UMLS CUI [4]
C0677081
UMLS CUI [5,1]
C0877248
UMLS CUI [5,2]
C0034869
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 and >65.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
concomitant hcv and/or hiv infection.
Description

Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019693
actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
Description

Liver Failure | Elevated total bilirubin | Prolonged prothrombin time (PT) | Serum albumin measurement | Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0741494
UMLS CUI [3]
C2673577
UMLS CUI [4]
C0523465
UMLS CUI [5]
C0003962
UMLS CUI [6]
C0333106
UMLS CUI [7]
C0019151
toxic or autoimmune hepatitis (ana titers > 1:160), metabolic liver diseases (wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
Description

Hepatitis, Toxic | Hepatitis, Autoimmune | Antinuclear antibodies (ANA) titer | Liver diseases Metabolic | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0019193
UMLS CUI [2]
C0241910
UMLS CUI [3]
C0373828
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0311400
UMLS CUI [5]
C0019202
UMLS CUI [6]
C0018995
UMLS CUI [7]
C0221757
women who are pregnant or nursing.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
Description

Leukopenia | Neutropenia | Hemoglobin measurement | Disease Severe | Cardiomyopathies | Diabetes Mellitus | Hypertensive disease | Neoplastic disease | nervous system disorder | Malnutrition

Data type

boolean

Alias
UMLS CUI [1]
C0023530
UMLS CUI [2]
C0027947
UMLS CUI [3]
C0518015
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0878544
UMLS CUI [6]
C0011849
UMLS CUI [7]
C0020538
UMLS CUI [8]
C1882062
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0162429
antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
Description

Antiviral Therapy | Immunomodulators | Steroid therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1527392
UMLS CUI [3]
C0149783
UMLS CUI [4]
C0392920
depression and/or psychiatric disorders.
Description

Depressive disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0004936
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Similar models

Eligibility Hepatitis D, Chronic NCT00686790

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Informed Consent
Item
participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
age 18-65 years old.
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
hbsag positive >6 months.
boolean
C0149709 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >= 2 uln >6 months.
boolean
C0151905 (UMLS CUI [1])
Hepatitis D virus RNA Seropositive
Item
hdv rna positive serology.
boolean
C0486926 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Serum antibody Hepatitis delta Antigens Immunoglobulin G | Serum antibody Hepatitis delta Antigens Immunoglobulin M
Item
serum antibody to hepatitis delta antigen of igg and igm class.
boolean
C3833453 (UMLS CUI [1,1])
C0057317 (UMLS CUI [1,2])
C0020852 (UMLS CUI [1,3])
C3833453 (UMLS CUI [2,1])
C0057317 (UMLS CUI [2,2])
C0020861 (UMLS CUI [2,3])
Knodell Fibrosis Score | Hepatitis delta Antigens Positive Biopsy of liver
Item
knodell score hai >= 6 and f >= 0; positive test for intrahepatic delta antigen in liver biopsy.
boolean
C3898641 (UMLS CUI [1])
C0057317 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Postmenopausal state | Sex Behavior | Hormonal contraception | Intrauterine Devices prescribed | Female Condoms | Vaginal Spermicides | Female Sterilization | Hysterectomy | Tubal Ligation
Item
women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed iud, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5,1])
C0278329 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0020699 (UMLS CUI [9])
C0520483 (UMLS CUI [10])
Disease Interferes with Clinical Trial Evaluation | Disease Free of | Hepatitis B, Chronic | Hepatitis D, Chronic
Item
participants must be free of any clinically significant disease (other than chronic hepatitis b and d), that would interfere with study evaluations.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0524909 (UMLS CUI [3])
C0524911 (UMLS CUI [4])
Protocol Compliance | maintain symptom diary | Severity of Symptom Scale | Medication record | Adverse event Records
Item
participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
boolean
C0525058 (UMLS CUI [1])
C2216446 (UMLS CUI [2])
C3897633 (UMLS CUI [3])
C0677081 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0034869 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18 and >65.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C | HIV Infection
Item
concomitant hcv and/or hiv infection.
boolean
C0019196 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Liver Failure | Elevated total bilirubin | Prolonged prothrombin time (PT) | Serum albumin measurement | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
boolean
C0085605 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C2673577 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C0333106 (UMLS CUI [6])
C0019151 (UMLS CUI [7])
Hepatitis, Toxic | Hepatitis, Autoimmune | Antinuclear antibodies (ANA) titer | Liver diseases Metabolic | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency
Item
toxic or autoimmune hepatitis (ana titers > 1:160), metabolic liver diseases (wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
boolean
C0019193 (UMLS CUI [1])
C0241910 (UMLS CUI [2])
C0373828 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
C0019202 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0221757 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
women who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Leukopenia | Neutropenia | Hemoglobin measurement | Disease Severe | Cardiomyopathies | Diabetes Mellitus | Hypertensive disease | Neoplastic disease | nervous system disorder | Malnutrition
Item
leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
boolean
C0023530 (UMLS CUI [1])
C0027947 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C0020538 (UMLS CUI [7])
C1882062 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0162429 (UMLS CUI [10])
Antiviral Therapy | Immunomodulators | Steroid therapy | Chemotherapy
Item
antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
boolean
C0280274 (UMLS CUI [1])
C1527392 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Depressive disorder | Mental disorders
Item
depression and/or psychiatric disorders.
boolean
C0011581 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
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