Eligibility Hepatitis B NCT00362700

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StudyEvent: Eligibility
1. Eligibility Hepatitis B NCT00362700

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Clevudine | l-fmau Clinical Trial

Item

1. patients who received clevudine in l-fmau-201 clinical trial (phase iib)

boolean

C0045212 (UMLS CUI [1])
C0045212 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Serum Beta-HCG Test Negative

Item

2. female of childbearing potential must have a negative serum ( b-hcg) pregnancy test within 14 days of starting therapy.

boolean

C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C1255526 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])

Informed Consent | Protocol Compliance

Item

3. 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])

Patient Visit | Follow-up visit Additional | Additional Therapy | Clevudine | HBV DNA decreased

Item

4. patients who met the following criteria after completion of the week 48 visit were to have additional follow-up visits at weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in hbv dna at week 48

boolean

C1512346 (UMLS CUI [1])
C0589121 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C1706712 (UMLS CUI [3])
C0045212 (UMLS CUI [4])
C1262160 (UMLS CUI [5])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Hbv DNA Test Negative

Item

1. hbv dna negative (< 4,700 copies/ml) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)

boolean

C1256114 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])

Antiviral Therapy | Biological Response Modifier Therapy | Steroid therapy

Item

2. patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.

boolean

C0280274 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C0149783 (UMLS CUI [3])

Item

3. patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for hbv infection after cessation of treatment in l-fmau-201 study.

boolean

C0209738 (UMLS CUI [1])
C0286536 (UMLS CUI [2])
C0050175 (UMLS CUI [3])
C0028621 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0019163 (UMLS CUI [5,2])
C0045212 (UMLS CUI [6,1])
C0008976 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C1272693 (UMLS CUI [6,4])

Ascites | Bleeding varices | Hepatic Encephalopathy

Item

4. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.

boolean

C0003962 (UMLS CUI [1])
C0333106 (UMLS CUI [2])
C0019151 (UMLS CUI [3])

HCV coinfection | Coinfection HDV | HIV coinfection

Item

5. patient is coinfected with hcv, hdv or hiv.

boolean

C1698259 (UMLS CUI [1])
C0275524 (UMLS CUI [2,1])
C0011220 (UMLS CUI [2,2])
C4062778 (UMLS CUI [3])

Liver Cirrhosis Evidence Clinical | Liver carcinoma Evidence Clinical | Alpha fetoprotein measurement | Sonography

Item

6. patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-fetoprotein) evaluation will be based on alpha-fetoprotein primarily. if alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.

boolean

C0023890 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0201539 (UMLS CUI [3])
C0041618 (UMLS CUI [4])

Pregnancy | Breast Feeding

Item

7. patient is pregnant or breast-feeding.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Item

8. 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. for males, condoms should be used. females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., iud, barrier methods with spermicide or abstinence)

boolean

C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0036899 (UMLS CUI [10])

Substance Use Disorders Relevant Clinical

Item

9. patient has a clinically relevant history of abuse of alcohol or drugs.

boolean

C0038586 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])

Item

10. patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.

boolean

C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C4075847 (UMLS CUI [3])
C1096000 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0020517 (UMLS CUI [8])

Estimation of creatinine clearance by Cockcroft-Gault formula

Item

11. patient has creatinine clearance less than 60ml/min as estimated by the following formula:

boolean

C2711451 (UMLS CUI [1])

Age | Body Weight | Creatinine measurement, serum | Gender

Item

(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dl]) [note: multiply estimates by 0.85 for women]

boolean

C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])

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Eligibility Hepatitis B NCT00362700