age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
chronic hepatitis c infection evidenced by a positive enzyme immunoassay for anti-hcv-antibodies and a positive quantitative rt-pcr amplification of hcv rna.
Item
chronic hepatitis c infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-hcv-antibodies and a positive quantitative rt-pcr amplification of hcv rna.
boolean
C0524910 (UMLS CUI [1])
C0086231 (UMLS CUI [2])
C0166049 (UMLS CUI [3])
C0369335 (UMLS CUI [4])
liver biopsy, chronic viral hepatitis
Item
chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
boolean
C0193388 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C0276623 (UMLS CUI [3])
hcv genotype 4
Item
hcv genotype 4.
boolean
C1148363 (UMLS CUI [1])
peginterferon
Item
patients that have not previously received peginterferon.
boolean
C0982327 (UMLS CUI [1])
patients unable to take oral medications
Item
patients unable to take oral medications.
boolean
C0175795 (UMLS CUI [1,1])
C3494765 (UMLS CUI [1,2])
ribavirin
Item
use of ribavirin within 30 days prior to enrollment.
boolean
C0035525 (UMLS CUI [1])
pregnant or breastfeeding, contraception, sexually active
Item
females who are either pregnant, breast-feeding or not using birth control and are sexually active.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0241028 (UMLS CUI [4])
investigational drug therapy
Item
any investigational drug therapy within 30 days prior to enrollment other than through romark study number rm01-3027.
boolean
C2348568 (UMLS CUI [1,1])
C0162778 (UMLS CUI [1,2])
liver disease
Item
patients with other causes of liver disease.
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
transplant recipients receiving immune suppression therapy.
Item
transplant recipients receiving immune suppression therapy.
boolean
C0376387 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
patient co-infected with human immunodeficiency virus, hepatitis a virus, hepatitis b virus, or hepatitis d virus
Item
patient co-infected with human immunodeficiency virus, hepatitis a virus, hepatitis b virus, or hepatitis d virus based on enzyme immunoassay.
boolean
C0275524 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0376325 (UMLS CUI [4])
C0011226 (UMLS CUI [5])
decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or ctp scores >6.
Item
patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or ctp scores >6.
boolean
C1619727 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
C0027947 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
alcohol consumption
Item
patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 grams per day.
boolean
C0001948 (UMLS CUI [1])
clinically unstable
Item
patients who are clinically unstable.
boolean
C0443343 (UMLS CUI [1])
comorbidity
Item
patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
boolean
C0009488 (UMLS CUI [1])
hypersensitivity to nitazoxanide or peg interferon alfa-2b
Item
history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.
boolean
C0020517 (UMLS CUI [1,1])
C0068788 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0796545 (UMLS CUI [2,2])