ID

27857

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01926288

Nyckelord

Versioner (1)
  1. 2017-12-02 2017-12-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT01926288

Engelsk

Eligibility Chronic Hepatitis B NCT01926288

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Chronic Hepatitis B HBeAg positive | Chronic Hepatitis B HBeAg negative

Datatyp

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
Beskrivning

Age

Datatyp

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.
Beskrivning

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

Datatyp

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 ×
Beskrivning

Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
uln.
Beskrivning

ID.5

Datatyp

boolean

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

Serum total bilirubin measurement

Datatyp

boolean

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

Prothrombin Activity Measurement | Prolonged prothrombin time

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Creatinine measurement, serum

Datatyp

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.
Beskrivning

Interferon | Nucleoside Analogs | alpha1-thymosin

Datatyp

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.
Beskrivning

Informed Consent | Compliance behavior

Datatyp

boolean

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

Exclusion Criteria

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

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

Datatyp

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.
Beskrivning

Liver Cirrhosis | Malignant neoplasm of liver

Datatyp

boolean

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

Study Subject Participation Status

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Metabolic Diseases | Autoimmune Diseases | Lupus Erythematosus, Systemic

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding | Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
Tillbaka till toppen

Similar models

Eligibility Chronic Hepatitis B NCT01926288

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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