ID

16770

Beschreibung

Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00418054

Link

https://clinicaltrials.gov/show/NCT00418054

Stichworte

Versionen (1)
  1. 05.08.16 05.08.16 -
Hochgeladen am

5. August 2016

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00418054

Englisch

Eligibility Chronic Hepatitis C NCT00418054

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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.
Beschreibung

chronic hepatitis c infection evidenced by a positive enzyme immunoassay for anti-hcv-antibodies and a positive quantitative rt-pcr amplification of hcv rna.

Datentyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C0086231
UMLS CUI [3]
C0166049
UMLS CUI [4]
C0369335
chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
Beschreibung

liver biopsy, chronic viral hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0011900
UMLS CUI [3]
C0276623
hcv genotype 4.
Beschreibung

hcv genotype 4

Datentyp

boolean

Alias
UMLS CUI [1]
C1148363
patients that have not previously received peginterferon.
Beschreibung

peginterferon

Datentyp

boolean

Alias
UMLS CUI [1]
C0982327
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients unable to take oral medications.
Beschreibung

patients unable to take oral medications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C3494765
use of ribavirin within 30 days prior to enrollment.
Beschreibung

ribavirin

Datentyp

boolean

Alias
UMLS CUI [1]
C0035525
females who are either pregnant, breast-feeding or not using birth control and are sexually active.
Beschreibung

pregnant or breastfeeding, contraception, sexually active

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0241028
any investigational drug therapy within 30 days prior to enrollment other than through romark study number rm01-3027.
Beschreibung

investigational drug therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0162778
patients with other causes of liver disease.
Beschreibung

liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
transplant recipients receiving immune suppression therapy.
Beschreibung

transplant recipients receiving immune suppression therapy.

Datentyp

boolean

Alias
UMLS CUI [1]
C0376387
UMLS CUI [2]
C0021079
patient co-infected with human immunodeficiency virus, hepatitis a virus, hepatitis b virus, or hepatitis d virus based on enzyme immunoassay.
Beschreibung

patient co-infected with human immunodeficiency virus, hepatitis a virus, hepatitis b virus, or hepatitis d virus

Datentyp

boolean

Alias
UMLS CUI [1]
C0275524
UMLS CUI [2]
C0019682
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0376325
UMLS CUI [5]
C0011226
patients with decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or ctp scores >6.
Beschreibung

decompensated cirrhosis, thrombocytopenia (platelet count <80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or ctp scores >6.

Datentyp

boolean

Alias
UMLS CUI [1]
C1619727
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0027947
UMLS CUI [4]
C0003962
UMLS CUI [5]
C0019151
patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of >20 grams per day.
Beschreibung

alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
patients who are clinically unstable.
Beschreibung

clinically unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0443343
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.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.
Beschreibung

hypersensitivity to nitazoxanide or peg interferon alfa-2b

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0068788
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0796545
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Ähnliche Modelle

Eligibility Chronic Hepatitis C NCT00418054

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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