Eligibility Hepatitis C, Chronic NCT01390844

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StudyEvent: Eligibility
1. Eligibility Hepatitis C, Chronic NCT01390844

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Chronic Hepatitis C Genotype

Item

previously documented chc genotype 1 infection. other or mixed genotypes are not eligible.

boolean

C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])

Biopsy of liver | Histology Consistent with Chronic Hepatitis C

Item

liver biopsy with histology consistent with chc and no other etiology.

boolean

C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])

Liver Cirrhosis Ultrasonography | Liver Cirrhosis Imaging study | Absence Liver findings Suspicious Liver carcinoma

Item

participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and day 1) with no findings suspicious for hepatocellular carcinoma

boolean

C0023890 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C1881134 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0426686 (UMLS CUI [3,2])
C0750493 (UMLS CUI [3,3])
C2239176 (UMLS CUI [3,4])

Prior Therapy failed | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin

Item

failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus rbv

boolean

C1514463 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0796545 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])

Body Weight

Item

weight between 40 kg and 125 kg, inclusive

boolean

C0005910 (UMLS CUI [1])

Ancestors Local

Item

of 'local' ancestral descent

boolean

C0870134 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])

Gender Sexually active Contraceptive methods | Childbearing Potential Contraceptive methods

Item

sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

boolean

C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Item

co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus

boolean

C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])

Interferon To be stopped | Ribavirin To be stopped | Adverse event Relationship Ribavirin | Adverse event Relationship Interferon

Item

required discontinuation of previous interferon or rbv regimen for an adverse event considered to be possibly or probably related to rbv and/or interferon

boolean

C3652465 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0035525 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C0877248 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3652465 (UMLS CUI [4,3])

Ribavirin Recent | Interferon-alpha Recent

Item

treatment with rbv within 90 days and any interferon-alpha within 1 month prior to screening

boolean

C0035525 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0002199 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])

Therapeutic procedure Hepatitis C | Investigational New Drugs | Herbal medicine Associated with Hepatotoxicity

Item

treatment for hepatitis c with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity

boolean

C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C2240391 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0235378 (UMLS CUI [3,3])

Investigational New Drugs | Study Subject Participation Status | Interventional Study

Item

treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit

boolean

C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C3274035 (UMLS CUI [3])

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Item

evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy

boolean

C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])

Diabetes | Hypertensive disease | On examination - eye findings Clinical Significance

Item

diabetes and/or hypertension with clinically significant ocular examination findings

boolean

C0011847 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0437530 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])

Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial

Item

any condition the could interfere with participation in and completion of the trial

boolean

C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])

Malignant Neoplasms | Malignant Neoplasm Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated

Item

evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)

boolean

C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])

Pregnancy | Breast Feeding

Item

pregnant or breast-feeding

boolean

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

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Eligibility Hepatitis C, Chronic NCT01390844