ID

44709

Description

Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir; ODM derived from: https://clinicaltrials.gov/show/NCT01023217

Link

https://clinicaltrials.gov/show/NCT01023217

Keywords

Versions (2)
  1. 4/12/18 4/12/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT01023217

English

Eligibility Hepatitis B, Chronic NCT01023217

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, 16 to 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. compensated liver disease(child-pugh class a)
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C4050412
3. hbsag positive at least 6 months or more
Description

Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0149709
4. hbeag positive or negative
Description

Hepatitis B e antigen positive | Hepatitis B e antigen negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948827
5. confirmation of lamivudine-resistance hbv mutation anytime before the study
Description

Lamivudine Resistance | HBV Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0209738
UMLS CUI [1,2]
C1514892
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0026882
6. patients with suboptimal response (hbv dna > 2000 iu/ml despite combination of adefovir [10 mg/day] plus lamivudine [100 mg/day] for 6 months or more). serum hbv dna should be determined by the pcr assay at the local laboratory at screening for this study
Description

Response Suboptimal | Hepatitis B DNA Measurement | Combined Modality Therapy | Adefovir | Lamivudine | Hepatitis B virus DNA Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C2984009
UMLS CUI [2]
C3641250
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0050175
UMLS CUI [5]
C0209738
UMLS CUI [6,1]
C0369332
UMLS CUI [6,2]
C0032520
7. patient is ambulatory.
Description

Patient Ambulatory

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0439841
8. patient is willing and able to comply with the study drug regimen and all other study requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
9. the patient is willing and able to provide written informed consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has a history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc, such as suspicious foci on imaging studies or elevated serum alpha fetoprotein (afp) levels. in patients with such findings, hcc should be ruled-out prior to randomizing the patient for the present study.
Description

Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma | Foci Suspicious Imaging studies | Elevated serum alpha-fetoprotein

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C2239176
UMLS CUI [3,1]
C0205234
UMLS CUI [3,2]
C0750493
UMLS CUI [3,3]
C1881134
UMLS CUI [4]
C3808572
2. patient previously received oral antiviral agent other than lamivudine or adefovir
Description

Antiviral Agents Oral | Exception Lamivudine | Exception Adefovir

Data type

boolean

Alias
UMLS CUI [1,1]
C0003451
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0209738
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0050175
3. patient has received interferon or other immunomodulatory treatment for hbv infection within 12 months before screening for this study.
Description

Interferon therapy Hepatitis B | Immunomodulation Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C0019163
4. patient has concomitant other chronic viral infection (hcv or hiv)
Description

Viral infections chronic | Hepatitis C, Chronic | Chronic infection with HIV

Data type

boolean

Alias
UMLS CUI [1,1]
C0042769
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0524910
UMLS CUI [3]
C0853112
5. patient has evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dl
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
6. patient has medical condition that requires use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
Description

Medical condition Requirement Prednisolone systemic | Medical condition Requirement Immunosuppressive Agents | Medical condition Requirement Chemotherapeutic agent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0032950
UMLS CUI [1,4]
C0205373
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0729502
7. patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
Description

Alcohol abuse | DRUG ABUSE ILLICIT

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0743253
8. patient is pregnant or breastfeeding or willing to be pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
9. patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis b (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
Description

Causes Primary Quantity Liver disease | Causes Secondary Quantity Liver disease | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Hepatitis, Autoimmune | Malignant Neoplasms Hepatic Involvement | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Condition Congenital Affecting Liver | Condition Metabolic Affecting Liver | Congestive heart failure | Cor pulmonale Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0023895
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0019163
UMLS CUI [4]
C0001973
UMLS CUI [5]
C0241910
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0441932
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0221757
UMLS CUI [9]
C0019202
UMLS CUI [10,1]
C0348080
UMLS CUI [10,2]
C1744681
UMLS CUI [10,3]
C0392760
UMLS CUI [10,4]
C0023884
UMLS CUI [11,1]
C0348080
UMLS CUI [11,2]
C0311400
UMLS CUI [11,3]
C0392760
UMLS CUI [11,4]
C0023884
UMLS CUI [12]
C0018802
UMLS CUI [13,1]
C0034072
UMLS CUI [13,2]
C0205082
10. a history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
Description

Malignant Neoplasms Treated allowed | Exception Liver carcinoma | Malignant Neoplasms In complete remission | Chemotherapy Absent | Surgical intervention Additional Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0677874
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C4035998
UMLS CUI [5,2]
C1524062
UMLS CUI [5,3]
C0332197
11. clinical signs of decompensated liver disease as indicated by any one of the following:
Description

Clinical signs Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C4075847
serum bilirubin > 3 mg/dl
Description

Serum bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428441
prothrombin time > 6 seconds prolonged or inr >1.6
Description

Prothrombin time increased | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2]
C0525032
serum albumin < 2.8 g/dl
Description

Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0523465
history of ascites, variceal hemorrhage, or hepatic encephalopathy
Description

Ascites | Bleeding varices | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0333106
UMLS CUI [3]
C0019151
child-pugh score ≥7
Description

Child-Pugh score

Data type

boolean

Alias
UMLS CUI [1]
C4050412
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Similar models

Eligibility Hepatitis B, Chronic NCT01023217

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female, 16 to 75 years of age
boolean
C0001779 (UMLS CUI [1])
Compensated liver disease Child-Pugh Classification
Item
2. compensated liver disease(child-pugh class a)
boolean
C3839044 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Hepatitis B surface antigen positive
Item
3. hbsag positive at least 6 months or more
boolean
C0149709 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B e antigen negative
Item
4. hbeag positive or negative
boolean
C0392390 (UMLS CUI [1])
C0948827 (UMLS CUI [2])
Lamivudine Resistance | HBV Mutation
Item
5. confirmation of lamivudine-resistance hbv mutation anytime before the study
boolean
C0209738 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
C0019169 (UMLS CUI [2,1])
C0026882 (UMLS CUI [2,2])
Response Suboptimal | Hepatitis B DNA Measurement | Combined Modality Therapy | Adefovir | Lamivudine | Hepatitis B virus DNA Polymerase Chain Reaction
Item
6. patients with suboptimal response (hbv dna > 2000 iu/ml despite combination of adefovir [10 mg/day] plus lamivudine [100 mg/day] for 6 months or more). serum hbv dna should be determined by the pcr assay at the local laboratory at screening for this study
boolean
C1704632 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0050175 (UMLS CUI [4])
C0209738 (UMLS CUI [5])
C0369332 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
Patient Ambulatory
Item
7. patient is ambulatory.
boolean
C0030705 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
Protocol Compliance
Item
8. patient is willing and able to comply with the study drug regimen and all other study requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
9. the patient is willing and able to provide written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma | Foci Suspicious Imaging studies | Elevated serum alpha-fetoprotein
Item
1. patient has a history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc, such as suspicious foci on imaging studies or elevated serum alpha fetoprotein (afp) levels. in patients with such findings, hcc should be ruled-out prior to randomizing the patient for the present study.
boolean
C2239176 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0205234 (UMLS CUI [3,1])
C0750493 (UMLS CUI [3,2])
C1881134 (UMLS CUI [3,3])
C3808572 (UMLS CUI [4])
Antiviral Agents Oral | Exception Lamivudine | Exception Adefovir
Item
2. patient previously received oral antiviral agent other than lamivudine or adefovir
boolean
C0003451 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0209738 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0050175 (UMLS CUI [3,2])
Interferon therapy Hepatitis B | Immunomodulation Hepatitis B
Item
3. patient has received interferon or other immunomodulatory treatment for hbv infection within 12 months before screening for this study.
boolean
C0279030 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Viral infections chronic | Hepatitis C, Chronic | Chronic infection with HIV
Item
4. patient has concomitant other chronic viral infection (hcv or hiv)
boolean
C0042769 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum
Item
5. patient has evidence of renal insufficiency defined as serum creatinine > 1.5 mg/dl
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Medical condition Requirement Prednisolone systemic | Medical condition Requirement Immunosuppressive Agents | Medical condition Requirement Chemotherapeutic agent
Item
6. patient has medical condition that requires use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0032950 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0729502 (UMLS CUI [3,3])
Alcohol abuse | DRUG ABUSE ILLICIT
Item
7. patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
8. patient is pregnant or breastfeeding or willing to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Causes Primary Quantity Liver disease | Causes Secondary Quantity Liver disease | Exception Hepatitis B | Alcoholic Intoxication, Chronic | Hepatitis, Autoimmune | Malignant Neoplasms Hepatic Involvement | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Hepatolenticular Degeneration | Condition Congenital Affecting Liver | Condition Metabolic Affecting Liver | Congestive heart failure | Cor pulmonale Severe
Item
9. patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis b (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
boolean
C0015127 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0023895 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0023895 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0019163 (UMLS CUI [3,2])
C0001973 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C0441932 (UMLS CUI [6,2])
C0018995 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C0019202 (UMLS CUI [9])
C0348080 (UMLS CUI [10,1])
C1744681 (UMLS CUI [10,2])
C0392760 (UMLS CUI [10,3])
C0023884 (UMLS CUI [10,4])
C0348080 (UMLS CUI [11,1])
C0311400 (UMLS CUI [11,2])
C0392760 (UMLS CUI [11,3])
C0023884 (UMLS CUI [11,4])
C0018802 (UMLS CUI [12])
C0034072 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
Malignant Neoplasms Treated allowed | Exception Liver carcinoma | Malignant Neoplasms In complete remission | Chemotherapy Absent | Surgical intervention Additional Absent
Item
10. a history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0677874 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C4035998 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Clinical signs Decompensated liver disease
Item
11. clinical signs of decompensated liver disease as indicated by any one of the following:
boolean
C3540840 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
Serum bilirubin measurement
Item
serum bilirubin > 3 mg/dl
boolean
C0428441 (UMLS CUI [1])
Prothrombin time increased | International Normalized Ratio
Item
prothrombin time > 6 seconds prolonged or inr >1.6
boolean
C0151872 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum albumin measurement
Item
serum albumin < 2.8 g/dl
boolean
C0523465 (UMLS CUI [1])
Ascites | Bleeding varices | Hepatic Encephalopathy
Item
history of ascites, variceal hemorrhage, or hepatic encephalopathy
boolean
C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
Child-Pugh score
Item
child-pugh score ≥7
boolean
C4050412 (UMLS CUI [1])
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