ID

39571

Description

Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02366247

Link

https://clinicaltrials.gov/show/NCT02366247

Keywords

Versions (1)
  1. 1/30/20 1/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B, Chronic NCT02366247

English

Eligibility Hepatitis B, Chronic NCT02366247

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis b for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
Description

Chronic Hepatitis B Disease length | Immunomodulatory therapy Rejected | Antiviral Therapy Rejected

Data type

boolean

Alias
UMLS CUI [1,1]
C0524909
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C1548437
UMLS CUI [3,1]
C0280274
UMLS CUI [3,2]
C1548437
alt level ＞ 2 × upper limit normal (uln).
Description

Alanine aminotransferase increased

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
positive hbeag and negative hbeab.
Description

Hepatitis B e antigen positive | Anti-HBe antibody negative

Data type

boolean

Alias
UMLS CUI [1]
C0392390
UMLS CUI [2]
C0948253
hbv-dna between 1.00e＋05 iu/ml and 9.99e＋09 iu/ml.
Description

Hepatitis B DNA Measurement

Data type

boolean

Alias
UMLS CUI [1]
C3641250
informed consent form (icf) signed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

boolean

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

Hepatitis, Autoimmune

Data type

boolean

Alias
UMLS CUI [1]
C0241910
hepatic cirrhosis.
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
serum creatinine ＞1.5 × uln or ccr ＜50 ml/min, haemoglobin ＜110g/l (male) or ＜100g/l (female), platelet＜80 e＋09/l, serum albumin ≤ 35g/l, or serum albumin/globulin (a/g)
Description

Serum creatinine raised | Creatinine clearance measurement | Hemoglobin measurement | Gender | Platelet Count measurement | Serum albumin measurement | Albumin to Globulin Ratio Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0373595
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0523465
UMLS CUI [7]
C2697980
≤0.9, neutrophile granulocyte ＜1.0 e＋09/l, prothrombin time＞uln＋3 seconds, cholinesterase＜4000u/l.
Description

Neutrophil count | Prothrombin time assay | Cholinesterase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0202207
hepatitic carcinoma or alpha fetal protein (afp) ＞100ng/ml .
Description

Other Coding | Alpha one fetoprotein measurement

Data type

boolean

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

Comorbidity Severe Affecting Therapy

Data type

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.
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
thymosin allergy.
Description

Hypersensitivity Thymosin

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Eligibility Hepatitis B, Chronic NCT02366247

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis B Disease length | Immunomodulatory therapy Rejected | Antiviral Therapy Rejected
Item
chronic hepatitis b for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
boolean
C0524909 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C1548437 (UMLS CUI [2,2])
C0280274 (UMLS CUI [3,1])
C1548437 (UMLS CUI [3,2])
Alanine aminotransferase increased
Item
alt level ＞ 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 | Anti-HBe antibody negative
Item
positive hbeag and negative hbeab.
boolean
C0392390 (UMLS CUI [1])
C0948253 (UMLS CUI [2])
Hepatitis B DNA Measurement
Item
hbv-dna between 1.00e＋05 iu/ml and 9.99e＋09 iu/ml.
boolean
C3641250 (UMLS CUI [1])
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 | Platelet Count measurement | Serum albumin measurement | Albumin to Globulin Ratio Measurement
Item
serum creatinine ＞1.5 × uln or ccr ＜50 ml/min, haemoglobin ＜110g/l (male) or ＜100g/l (female), platelet＜80 e＋09/l, serum albumin ≤ 35g/l, or serum albumin/globulin (a/g)
boolean
C0700225 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0523465 (UMLS CUI [6])
C2697980 (UMLS CUI [7])
Neutrophil count | Prothrombin time assay | Cholinesterase measurement
Item
≤0.9, neutrophile granulocyte ＜1.0 e＋09/l, prothrombin time＞uln＋3 seconds, cholinesterase＜4000u/l.
boolean
C0200633 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0202207 (UMLS CUI [3])
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])
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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