Criteria Fulfill
Item
patients eligible for inclusion in this study have to fulfill all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Chronic hepatitis C genotype 1
Item
chronic hepatitis c genotype-1
boolean
C4049392 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv-rna should be ≥ 4 x 105 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Interferon Long-term Active | Ribavirin Long-term Active | Hepatitis C RNA negative | Relapse | Hepatitis C RNA positive Post Therapeutic procedure Discontinued | Therapeutic procedure To be stopped
Item
recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum hcv rna on treatment, who subsequently becomes serum hcv rna positive after stopping treatment ("relapser"). patients must have been off all treatment for at least 3 months prior to start of study (visit
boolean
C0021747 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C0205177 (UMLS CUI [2,3])
C0855841 (UMLS CUI [3])
C0035020 (UMLS CUI [4])
C0855842 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
C1444662 (UMLS CUI [5,4])
C0087111 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
Therapeutic procedure Hepatitis C
Item
use of any hcv treatment ≤ 3months prior to study start
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Investigational Therapy Against Hepatitis C virus | Exception Interferon | Exception Ribavirin
Item
prior receipt of any investigational anti-hcv therapy which is not ifn or rbv
boolean
C0949266 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021747 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
Childbearing Potential | Exception Postmenopausal state | Exception Contraceptive methods Use of
Item
women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1524063 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Cirrhosis | Hepatic decompensation | Exception Hepatitis C | Exception Hepatitis B | Exception HIV Infection
Item
evidence of cirrhosis, hepatic decompensation, other than hcv liver disease, hbv or hiv infection
boolean
C0023890 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0019163 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0019693 (UMLS CUI [5,2])
Laboratory test result abnormal Specified | Abnormal Hemoglobin | White blood cell abnormality | Absolute neutrophil count abnormal | Abnormal platelets
Item
specified abnormalities in lab values of amongst others hemoglobin, wbc, anc, platelets
boolean
C0438215 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0019047 (UMLS CUI [2])
C0152009 (UMLS CUI [3])
C1262264 (UMLS CUI [4])
C0151854 (UMLS CUI [5])
Therapeutic procedure Depressive disorder
Item
history of treatment for depression
boolean
C0087111 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
Steroids | Immunosuppressive Agents | Clinical Trial Eligibility Criteria Study Protocol
Item
steroid/immunosuppression drug use 3 months prior to study start other protocol-defined inclusion/exclusion criteria may apply
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C1516637 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])