ID

39570

Beschrijving

Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02366208

Link

https://clinicaltrials.gov/show/NCT02366208

Trefwoorden

Versies (2)
  1. 30-01-20 30-01-20 -
  2. 30-01-20 30-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02366208

Engels

Eligibility Hepatitis B, Chronic NCT02366208

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b for more than 6 months
Beschrijving

Chronic Hepatitis B Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0872146
alt ＞ 2 × upper limit normal (uln)
Beschrijving

Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
serum bilirubin ＜ 2 × uln.
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
positive hbeag and hbv-dna between 1.00e＋05 iu/ml and 9.99e＋09 iu/ml.
Beschrijving

Hepatitis B e antigen positive | Hepatitis B DNA Measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C3641250
informed consent form (icf) signed.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis a,c,d,e or hiv infection.
Beschrijving

Hepatitis A | Hepatitis C | Hepatitis D Infection | Hepatitis E | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0011226
UMLS CUI [4]
C0085293
UMLS CUI [5]
C0019693
autoimmune hepatitis.
Beschrijving

Hepatitis, Autoimmune

Datatype

boolean

Alias
UMLS CUI [1]
C0241910
hepatic cirrhosis.
Beschrijving

Liver Cirrhosis

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
serum creatinine ＞ 1.5 × uln or ccr ＜ 50 ml/min, haemoglobin ＜ 110g/l (male) or ＜
Beschrijving

Serum creatinine raised | Creatinine clearance measurement | Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
100g/l (female), platelet＜ 80 e＋09/l, serum albumin ≤ 32g/l, or serum albumin/globulin (a/g) ≤0.9, neutrophile granulocyte ＜ 1.0 e＋09/l, prothrombin time＞uln＋3 seconds, cholinesterase＜2500u/l.
Beschrijving

Platelet Count measurement | Serum albumin measurement | Albumin to Globulin Ratio Measurement | Neutrophil count | Prothrombin time assay | Cholinesterase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0523465
UMLS CUI [3]
C2697980
UMLS CUI [4]
C0200633
UMLS CUI [5]
C0033707
UMLS CUI [6]
C0202207
hepatitic carcinoma or alpha fetal protein (afp) ＞ 100ng/ml
Beschrijving

Other Coding | Alpha one fetoprotein measurement

Datatype

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0201539
patients with other severe diseases combined, which could affect the therapy.
Beschrijving

Comorbidity Severe Affecting Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0087111
patients accepted other clinical trial within 6 months before the first administrated.
Beschrijving

Study Subject Participation Status | Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
patients accepted immunomodulating or anti-viral treatment within 6 months before the trial.
Beschrijving

Immunomodulatory therapy | Antiviral Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0280274
patients with autoimmune disease.
Beschrijving

Autoimmune Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
thymosin allergy.
Beschrijving

Hypersensitivity Thymosin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0040106
pregnant or breast feeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatitis B, Chronic NCT02366208

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis B Disease length
Item
chronic hepatitis b for more than 6 months
boolean
C0524909 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Alanine aminotransferase increased
Item
alt ＞ 2 × upper limit normal (uln)
boolean
C0151905 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin ＜ 2 × uln.
boolean
C1278039 (UMLS CUI [1])
Hepatitis B e antigen positive | Hepatitis B DNA Measurement
Item
positive hbeag and hbv-dna between 1.00e＋05 iu/ml and 9.99e＋09 iu/ml.
boolean
C0392390 (UMLS CUI [1])
C3641250 (UMLS CUI [2])
Informed Consent
Item
informed consent form (icf) signed.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis A | Hepatitis C | Hepatitis D Infection | Hepatitis E | HIV Infection
Item
hepatitis a,c,d,e or hiv infection.
boolean
C0019159 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0011226 (UMLS CUI [3])
C0085293 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
Hepatitis, Autoimmune
Item
autoimmune hepatitis.
boolean
C0241910 (UMLS CUI [1])
Liver Cirrhosis
Item
hepatic cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Serum creatinine raised | Creatinine clearance measurement | Hemoglobin measurement | Gender
Item
serum creatinine ＞ 1.5 × uln or ccr ＜ 50 ml/min, haemoglobin ＜ 110g/l (male) or ＜
boolean
C0700225 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Platelet Count measurement | Serum albumin measurement | Albumin to Globulin Ratio Measurement | Neutrophil count | Prothrombin time assay | Cholinesterase measurement
Item
100g/l (female), platelet＜ 80 e＋09/l, serum albumin ≤ 32g/l, or serum albumin/globulin (a/g) ≤0.9, neutrophile granulocyte ＜ 1.0 e＋09/l, prothrombin time＞uln＋3 seconds, cholinesterase＜2500u/l.
boolean
C0032181 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
C2697980 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
C0033707 (UMLS CUI [5])
C0202207 (UMLS CUI [6])
Other Coding | Alpha one fetoprotein measurement
Item
hepatitic carcinoma or alpha fetal protein (afp) ＞ 100ng/ml
boolean
C3846158 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
Comorbidity Severe Affecting Therapy
Item
patients with other severe diseases combined, which could affect the therapy.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Study Subject Participation Status | Clinical Trial
Item
patients accepted other clinical trial within 6 months before the first administrated.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Immunomodulatory therapy | Antiviral Therapy
Item
patients accepted immunomodulating or anti-viral treatment within 6 months before the trial.
boolean
C1963758 (UMLS CUI [1])
C0280274 (UMLS CUI [2])
Autoimmune Disease
Item
patients with autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Hypersensitivity Thymosin
Item
thymosin allergy.
boolean
C0020517 (UMLS CUI [1,1])
C0040106 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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