ID

29437

Beschreibung

A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+); ODM derived from: https://clinicaltrials.gov/show/NCT01264367

Link

https://clinicaltrials.gov/show/NCT01264367

Stichworte

Versionen (1)
  1. 24.03.18 24.03.18 -
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See clinicaltrials.gov

Hochgeladen am

24. März 2018

DOI

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Eligibility HBeAg(+) Chronic Hepatitis B NCT01264367

Englisch

Eligibility HBeAg(+) Chronic Hepatitis B NCT01264367

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is between 18~60 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient is hbv dna positive with dna levels ≥ 5 x 10^5 copies/ml within 30 days of baseline.
Beschreibung

Hbv DNA Test Positive | Hepatitis B DNA Measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1256114
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C3641250
3. patient is documented to be hbsag positive for > 6 months and patient is hbeag positive.
Beschreibung

Hepatitis B surface antigen positive | Hepatitis B e antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0392390
4. patient has alt levels >=80iu/l, prothrombin time(inr)<1.7 and a serum albumin level of at least 3.5 g/dl.
Beschreibung

Alanine aminotransferase measurement | Prothrombin time international normalized ratio (PT-INR) | Serum albumin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1821762
UMLS CUI [3]
C0523465
5. patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
Beschreibung

Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
6. women of childbearing potential must have a negative urine pregnancy test(β-hcg) taken within 14 days of starting therapy.
Beschreibung

Childbearing Potential Urine pregnancy test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430056
UMLS CUI [1,3]
C1513916
7. patient is able to give written informed consent prior to study start and to comply with the study requirements.
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Beschreibung

Antiviral Therapy | Immunomodulation | Cytotoxic Chemotherapy | Steroid therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0280274
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0149783
2. patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection.
Beschreibung

Interferon | pegylated interferon alfa | Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Tenofovir | Nucleoside Investigational Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0907160
UMLS CUI [3]
C0045212
UMLS CUI [4]
C0209738
UMLS CUI [5]
C0050175
UMLS CUI [6]
C0971023
UMLS CUI [7]
C1453933
UMLS CUI [8]
C0384228
UMLS CUI [9,1]
C0028621
UMLS CUI [9,2]
C1517586
UMLS CUI [9,3]
C0019163
3. patient is coinfected with hcv or hiv.
Beschreibung

HCV coinfection | HIV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C1698259
UMLS CUI [2]
C4062778
4. patient with clinical evidence of decompensated liver disease or hcc
Beschreibung

Decompensated liver disease | Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C2239176
5. patient has wbc levels < 3.0x10^9/l
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
6. patient has platelets levels < 90x10^9/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
7. patient has alpha fetoprotein levels > 100ng/ml
Beschreibung

Alpha one fetoprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201539
8. patient has a history of thyroid disease.
Beschreibung

Thyroid Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0040128
9. patient has a history of autoimmune hepatitis.
Beschreibung

Hepatitis, Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
10. patient is pregnant or breast-feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
Beschreibung

Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
12. patient has a clinically relevant history of abuse of alcohol or drugs.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
13. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
Beschreibung

Immune System Diseases | Gastrointestinal Diseases | Kidney Diseases | Hematological Disease | Mental disorders | Bronchopulmonary disease | Gall Bladder Diseases | Exception Cholecystolithiasis Asymptomatic | Nervous system disorder | Heart Diseases | Disease Oncologic | Hypersensitivity | Illness Interferes with Therapeutic procedure | Benign Neoplasm Interferes with Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0004936
UMLS CUI [6]
C1096000
UMLS CUI [7]
C0016977
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0947622
UMLS CUI [8,3]
C0231221
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0018799
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0205478
UMLS CUI [12]
C0020517
UMLS CUI [13,1]
C0221423
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C0087111
UMLS CUI [14,1]
C0086692
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C2732579
14. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
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Ähnliche Modelle

Eligibility HBeAg(+) Chronic Hepatitis B NCT01264367

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is between 18~60 years
boolean
C0001779 (UMLS CUI [1])
Hbv DNA Test Positive | Hepatitis B DNA Measurement
Item
2. patient is hbv dna positive with dna levels ≥ 5 x 10^5 copies/ml within 30 days of baseline.
boolean
C1256114 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3641250 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
3. patient is documented to be hbsag positive for > 6 months and patient is hbeag positive.
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Alanine aminotransferase measurement | Prothrombin time international normalized ratio (PT-INR) | Serum albumin measurement
Item
4. patient has alt levels >=80iu/l, prothrombin time(inr)<1.7 and a serum albumin level of at least 3.5 g/dl.
boolean
C0201836 (UMLS CUI [1])
C1821762 (UMLS CUI [2])
C0523465 (UMLS CUI [3])
Hemoglobin measurement | Gender
Item
5. patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test Negative
Item
6. women of childbearing potential must have a negative urine pregnancy test(β-hcg) taken within 14 days of starting therapy.
boolean
C3831118 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Informed Consent | Protocol Compliance
Item
7. patient is able to give written informed consent prior to study start and to comply with the study requirements.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Antiviral Therapy | Immunomodulation | Cytotoxic Chemotherapy | Steroid therapy
Item
1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
boolean
C0280274 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0149783 (UMLS CUI [4])
Interferon | pegylated interferon alfa | Clevudine | Lamivudine | adefovir | entecavir | telbivudine | Tenofovir | Nucleoside Investigational Hepatitis B
Item
2. patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection.
boolean
C3652465 (UMLS CUI [1])
C0907160 (UMLS CUI [2])
C0045212 (UMLS CUI [3])
C0209738 (UMLS CUI [4])
C0050175 (UMLS CUI [5])
C0971023 (UMLS CUI [6])
C1453933 (UMLS CUI [7])
C0384228 (UMLS CUI [8])
C0028621 (UMLS CUI [9,1])
C1517586 (UMLS CUI [9,2])
C0019163 (UMLS CUI [9,3])
HCV coinfection | HIV coinfection
Item
3. patient is coinfected with hcv or hiv.
boolean
C1698259 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Decompensated liver disease | Liver carcinoma
Item
4. patient with clinical evidence of decompensated liver disease or hcc
boolean
C4075847 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
White Blood Cell Count procedure
Item
5. patient has wbc levels < 3.0x10^9/l
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
6. patient has platelets levels < 90x10^9/l
boolean
C0032181 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
7. patient has alpha fetoprotein levels > 100ng/ml
boolean
C0201539 (UMLS CUI [1])
Thyroid Disease
Item
8. patient has a history of thyroid disease.
boolean
C0040128 (UMLS CUI [1])
Hepatitis, Autoimmune
Item
9. patient has a history of autoimmune hepatitis.
boolean
C0241910 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
10. patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
11. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Substance Use Disorders
Item
12. patient has a clinically relevant history of abuse of alcohol or drugs.
boolean
C0038586 (UMLS CUI [1])
Immune System Diseases | Gastrointestinal Diseases | Kidney Diseases | Hematological Disease | Mental disorders | Bronchopulmonary disease | Gall Bladder Diseases | Exception Cholecystolithiasis Asymptomatic | Nervous system disorder | Heart Diseases | Disease Oncologic | Hypersensitivity | Illness Interferes with Therapeutic procedure | Benign Neoplasm Interferes with Completion of clinical trial
Item
13. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
boolean
C0021053 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C1096000 (UMLS CUI [6])
C0016977 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C0947622 (UMLS CUI [8,2])
C0231221 (UMLS CUI [8,3])
C0027765 (UMLS CUI [9])
C0018799 (UMLS CUI [10])
C0012634 (UMLS CUI [11,1])
C0205478 (UMLS CUI [11,2])
C0020517 (UMLS CUI [12])
C0221423 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0087111 (UMLS CUI [13,3])
C0086692 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C2732579 (UMLS CUI [14,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
14. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]
boolean
C2711451 (UMLS CUI [1])
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