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ID
19988
Beschreibung
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00372385
Link
https://clinicaltrials.gov/show/NCT00372385
Stichworte
Versionen (2)
- 02.02.17 02.02.17 -
- 03.02.17 03.02.17 -
Hochgeladen am
2. Februar 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Chronic Hepatitis C NCT00372385
Eligibility Chronic Hepatitis C NCT00372385
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Chronic Hepatitis C NCT00372385
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Hepatitis C virus genotype 1 | Hepatitis C RNA positive
Item
hepatitis c virus genotype 1 with detectable plasma hepatitis c virus rna
boolean
C3532919 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
C0855842 (UMLS CUI [2])
Hepatitis C virus infection Disease length
Item
have been infected with hepatitis c virus for greater than (>) 6 months
boolean
C3844790 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Hepatitis B Surface Antigens Seronegative | HIV-1 Seronegative | HIV-2 Seronegative
Item
seronegative for hepatitis b surface antigen and human immunodeficiency virus 1 and 2
boolean
C0019168 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019704 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0019707 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
C0521144 (UMLS CUI [1,2])
C0019704 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0019707 (UMLS CUI [3,1])
C0521144 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Quantity | Contraception, Barrier
Item
must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2])
Gender Pregnancy test negative
Item
female subjects must have a negative pregnancy test at all visits before the first dose.
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0427780 (UMLS CUI [1,2])
Pharmaceutical Preparations Approved Hepatitis C | Investigational New Drugs Hepatitis C
Item
received any approved or investigational drug or drug regimen for the treatment of hepatitis c.
boolean
C0013227 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0205540 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Medical contraindication peginterferon alfa-2a | Medical contraindication Ribavirin
Item
any medical contraindications to peg-ifn-alfa-2a or ribavirin therapy
boolean
C1301624 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
C0391001 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver disease Significant Cause | Hepatitis C | Hepatitis B | Drug-induced cirrhosis of liver | Liver Cirrhosis, Alcoholic | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
any other cause of significant liver disease in addition to hepatitis c; this may include but is not limited to, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis or primary biliary cirrhosis.
boolean
C0023895 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C1960179 (UMLS CUI [4])
C0023891 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C3241937 (UMLS CUI [9])
C0008312 (UMLS CUI [10])
C0750502 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C1960179 (UMLS CUI [4])
C0023891 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C3241937 (UMLS CUI [9])
C0008312 (UMLS CUI [10])
Liver carcinoma | Liver carcinoma Suspected
Item
diagnosed or suspected hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
Liver Cirrhosis Evidence Biopsy of liver | Compensated cirrhosis Biopsy of liver
Item
histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start.
boolean
C0023890 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1608426 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0332120 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1608426 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Alcohol abuse | Alcohol intake above recommended sensible limits
Item
alcohol/drug abuse or excessive use in the last 12 months.
boolean
C0085762 (UMLS CUI [1])
C0560219 (UMLS CUI [2])
C0560219 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Drug study Quantity Participation
Item
participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013175 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
C0013230 (UMLS CUI [2])
C0013175 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])