ID

27857

Descrição

Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT01926288

Link

https://clinicaltrials.gov/show/NCT01926288

Palavras-chave

Versões (1)
  1. 02/12/2017 02/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de dezembro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT01926288

Inglês

Eligibility Chronic Hepatitis B NCT01926288

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects diagnosed of hbeag positive or negative chronic hepatitis b
Descrição

Chronic Hepatitis B HBeAg positive | Chronic Hepatitis B HBeAg negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0392390
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0948827
2. aged 18 to 70 years old，male or female
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. patients with previously hbsag-positive, hbeag-positive for 24 weeks, hbv-dna> 105copies/ml. hbeag-negative for 24 weeks or more, hbv-dna> 105 copies/ml.
Descrição

Hepatitis B surface antigen positive | HBeAg positive | Hepatitis B DNA Measurement | HBeAg negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
UMLS CUI [3]
C3641250
UMLS CUI [4]
C0948827
4. 1.3 times the upper normal limit (1.3 × uln) ≤ alanine aminotransferase (alt) ≤ 10 ×
Descrição

Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151905
uln.
Descrição

ID.5

Tipo de dados

boolean

5. total serum bilirubin (tbil) ≤ 2.5 × uln.
Descrição

Serum total bilirubin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
6. prothrombin activity (pta) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
Descrição

Prothrombin Activity Measurement | Prolonged prothrombin time

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274435
UMLS CUI [2]
C2673577
7. wbc ≥ 3.5 × 109 / l, plt ≥ 70 × 109 / l, serum albumin (alb)≥ 35 g / l.
Descrição

White Blood Cell Count procedure | Platelet Count measurement | Serum albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0523465
8. creatinine (cr) ≤ 1.5 × uln.
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
9. if patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
Descrição

Interferon | Nucleoside Analogs | alpha1-thymosin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C1579410
UMLS CUI [3]
C0076612
10. patients signed an informed consent form and compliance was good.
Descrição

Informed Consent | Compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients were infected with other viruses as hav, hcv, hdv, hev, cmv, ebv, hiv etc.
Descrição

Hepatitis A | Hepatitis C | Hepatitis D Infection | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | HIV Infections

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0011226
UMLS CUI [4]
C0085293
UMLS CUI [5]
C0010823
UMLS CUI [6]
C0149678
UMLS CUI [7]
C0019693
2. patients with cirrhosis or liver cancer.
Descrição

Liver Cirrhosis | Malignant neoplasm of liver

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0345904
3. patients have participated in another therapeutic clinical trial in 3 months.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
4. granulocyte count <1.5 × 109 / l, hemoglobin (hb)<100g / l, sera alpha-fetoprotein(afp)> 100μg / l, patients' b ultrasonography pointed space-occupying lesions.
Descrição

Granulocyte count | Hemoglobin measurement | Serum alpha-fetoprotein (AFP) measurement | Space-occupying lesion B mode ultrasound

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0546833
UMLS CUI [4,1]
C0332562
UMLS CUI [4,2]
C1302166
5. patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
Descrição

Heart Diseases Severe | Kidney Diseases Severe | Endocrine System Diseases Severe | Hematological Disease Severe | Neuropsychiatric syndrome Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C3203509
UMLS CUI [5,2]
C0205082
6. patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
Descrição

Metabolic Diseases | Autoimmune Diseases | Lupus Erythematosus, Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0024141
7. pregnant woman, lactating women or those who wre allergic for study drug.
Descrição

Pregnancy | Breast Feeding | Hypersensitivity Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
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Similar models

Eligibility Chronic Hepatitis B NCT01926288

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis B HBeAg positive | Chronic Hepatitis B HBeAg negative
Item
1. subjects diagnosed of hbeag positive or negative chronic hepatitis b
boolean
C0524909 (UMLS CUI [1,1])
C0392390 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0948827 (UMLS CUI [2,2])
Age
Item
2. aged 18 to 70 years old，male or female
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive | HBeAg positive | Hepatitis B DNA Measurement | HBeAg negative
Item
3. patients with previously hbsag-positive, hbeag-positive for 24 weeks, hbv-dna> 105copies/ml. hbeag-negative for 24 weeks or more, hbv-dna> 105 copies/ml.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
C3641250 (UMLS CUI [3])
C0948827 (UMLS CUI [4])
Alanine aminotransferase increased
Item
4. 1.3 times the upper normal limit (1.3 × uln) ≤ alanine aminotransferase (alt) ≤ 10 ×
boolean
C0151905 (UMLS CUI [1])
ID.5
Item
uln.
boolean
Serum total bilirubin measurement
Item
5. total serum bilirubin (tbil) ≤ 2.5 × uln.
boolean
C1278039 (UMLS CUI [1])
Prothrombin Activity Measurement | Prolonged prothrombin time
Item
6. prothrombin activity (pta) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
boolean
C3274435 (UMLS CUI [1])
C2673577 (UMLS CUI [2])
White Blood Cell Count procedure | Platelet Count measurement | Serum albumin measurement
Item
7. wbc ≥ 3.5 × 109 / l, plt ≥ 70 × 109 / l, serum albumin (alb)≥ 35 g / l.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
Creatinine measurement, serum
Item
8. creatinine (cr) ≤ 1.5 × uln.
boolean
C0201976 (UMLS CUI [1])
Interferon | Nucleoside Analogs | alpha1-thymosin
Item
9. if patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
boolean
C3652465 (UMLS CUI [1])
C1579410 (UMLS CUI [2])
C0076612 (UMLS CUI [3])
Informed Consent | Compliance behavior
Item
10. patients signed an informed consent form and compliance was good.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hepatitis A | Hepatitis C | Hepatitis D Infection | Hepatitis E | Cytomegalovirus Infections | Epstein-Barr Virus Infections | HIV Infections
Item
1. patients were infected with other viruses as hav, hcv, hdv, hev, cmv, ebv, hiv etc.
boolean
C0019159 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0085293 (UMLS CUI [4])
C0010823 (UMLS CUI [5])
C0149678 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
Liver Cirrhosis | Malignant neoplasm of liver
Item
2. patients with cirrhosis or liver cancer.
boolean
C0023890 (UMLS CUI [1])
C0345904 (UMLS CUI [2])
Study Subject Participation Status
Item
3. patients have participated in another therapeutic clinical trial in 3 months.
boolean
C2348568 (UMLS CUI [1])
Granulocyte count | Hemoglobin measurement | Serum alpha-fetoprotein (AFP) measurement | Space-occupying lesion B mode ultrasound
Item
4. granulocyte count <1.5 × 109 / l, hemoglobin (hb)<100g / l, sera alpha-fetoprotein(afp)> 100μg / l, patients' b ultrasonography pointed space-occupying lesions.
boolean
C0857490 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0546833 (UMLS CUI [3])
C0332562 (UMLS CUI [4,1])
C1302166 (UMLS CUI [4,2])
Heart Diseases Severe | Kidney Diseases Severe | Endocrine System Diseases Severe | Hematological Disease Severe | Neuropsychiatric syndrome Severe
Item
5. patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0014130 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3203509 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Metabolic Diseases | Autoimmune Diseases | Lupus Erythematosus, Systemic
Item
6. patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
boolean
C0025517 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
Pregnancy | Breast Feeding | Hypersensitivity Investigational New Drugs
Item
7. pregnant woman, lactating women or those who wre allergic for study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
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