Eligibility Hepatitis C, Chronic NCT02254707

1 Formulários

StudyEvent: Eligibility
1. Eligibility Hepatitis C, Chronic NCT02254707

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Adult | Age

Item

1. adult males from 18 - 65 years

boolean

C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

Informed Consent

Item

2. written informed consent consistent with ich (international conference on harmonisation)/gcp (good clinical practice) and local legislation given prior to any study procedures

boolean

C0021430 (UMLS CUI [1])

Hepatitis C, Chronic | Hepatitis C Antibodies Immunoglobulin G Positive

Item

3. chronic hcv infection demonstrated by positive hcv igg antibody

boolean

C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])

Hepatitis C virus genotype

Item

4. hcv genotype 1 which has to be confirmed by central laboratory test before visit 2

boolean

C1148363 (UMLS CUI [1])

Item

5. liver biopsy consistent with active hepatitis c virus (hcv) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (ishak or metavir grade <= 2)

boolean

C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0239946 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C0239946 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4])
C2986945 (UMLS CUI [5])
C3888527 (UMLS CUI [6])

HCV viral load

Item

6. hcv ribonucleic acid (rna) load greater than 100,000 iu rna per ml serum at screening

boolean

C1868902 (UMLS CUI [1])

Alcohol Abstinence Willing

Item

7. willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)

boolean

C0678274 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Item

1. males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (iud).

boolean

C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0009653 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
C2985296 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0021900 (UMLS CUI [9])

Chronic liver disease Etiology aspects | Virus Causing Hepatitis

Item

2. any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis

boolean

C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0042776 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019158 (UMLS CUI [2,3])

Decompensated liver disease Evidence of | Ascites | Hypertension, Portal | Hepatic Encephalopathy

Item

3. evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy

boolean

C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0020541 (UMLS CUI [3])
C0019151 (UMLS CUI [4])

HIV Seropositivity | Hepatitis B surface antigen positive

Item

4. positive test for human immunodeficiency virus (hiv) or hepatitis b surface (hbs) antigen at screening

boolean

C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])

Substance Use Disorders

Item

5. current alcohol or drug abuse, or history of the same, within the past twelve (12) months. all patients must abstain from alcohol from enrolment until completion of the study (visit 11).

boolean

C0038586 (UMLS CUI [1])

Comorbidity Requirement Therapeutic procedure | Comorbidity Requirement Pharmaceutical Preparations

Item

6. any concurrent medical illness or disease requiring treatment or concomitant medications

boolean

C0009488 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])

Malignant Neoplasms | Squamous cell carcinoma cured | Basal cell carcinoma cured

Item

7. history of malignancy (except for previously cured squamous cell or basal cell carcinoma)

boolean

C0006826 (UMLS CUI [1])
C0007137 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])

Investigational New Drugs

Item

8. usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study

boolean

C0013230 (UMLS CUI [1])

interferon | Ribavirin

Item

9. patients treated with interferon and/or ribavirin within 6 months prior to screening

boolean

C0733470 (UMLS CUI [1])
C0035525 (UMLS CUI [2])

Pharmacotherapy | Antiviral Therapy | Vaccination

Item

10. planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination

boolean

C0013216 (UMLS CUI [1])
C0280274 (UMLS CUI [2])
C0042196 (UMLS CUI [3])

Drug Allergy | Hypersensitivity Pharmaceutical Excipient

Item

11. known hypersensitivity to drugs or excipients

boolean

C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])

Laboratory Results

Item

12. patients with any one of the following laboratory values at screening:

boolean

C1254595 (UMLS CUI [1])

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Item

alanine transaminase (alt) or aspartate transaminase (ast) > 2.5 x upper limit of normal (uln) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)

boolean

C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])

Serum total bilirubin measurement

Item

total bilirubin > 1x uln

boolean

C1278039 (UMLS CUI [1])

Alkaline phosphatase measurement

Item

alkaline phosphatase > 1.5x uln

boolean

C0201850 (UMLS CUI [1])

Prothrombin time | INR | Prothrombin time increased

Item

prothrombin time (inr, prolonged) > 1.5

boolean

C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0151872 (UMLS CUI [3])

Platelet Count measurement

Item

platelet count < 100,000 / mm3

boolean

C0032181 (UMLS CUI [1])

Hemoglobin

Item

hemoglobin < 10.5 g/dl

boolean

C0019046 (UMLS CUI [1])

White Blood Cell Count procedure

Item

white blood cell count < 2,000 / mm3

boolean

C0023508 (UMLS CUI [1])

LABORATORY ABNORMALITIES Clinical Significance

Item

13. patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening

boolean

C1853129 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])

Urinalysis Positive Drug abuse

Item

14. positive urine test for drug abuse at screening

boolean

C0042014 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,3])

Gilbert Disease

Item

15. patients with known gilbert's disease

boolean

C0017551 (UMLS CUI [1])

Study Subject Participation Status | Investigational New Drugs

Item

16. prior randomisation to active treatment with bilb 1941 zw into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. to support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately

boolean

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

Protocol Compliance Unable

Item

17. inability to comply with the protocol

boolean

C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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Eligibility Hepatitis C, Chronic NCT02254707