ID

19993

Descripción

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00421434

Link

https://clinicaltrials.gov/show/NCT00421434

Palabras clave

Versiones (1)
  1. 2/2/17 2/2/17 -
Subido en

2 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00421434

Inglés

Eligibility Chronic Hepatitis C NCT00421434

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years.
Descripción

Age

Tipo de datos

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.
Descripción

Chronic Hepatitis C Disease length Evidence of | Hepatitis C Antibodies Enzyme Immunoassay Positive | Reverse Transcriptase Polymerase Chain Reaction Quantitative Positive | Hepatitis C virus RNA amplification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0086231
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0599161
UMLS CUI [3,2]
C0392762
UMLS CUI [3,3]
C1514241
UMLS CUI [4,1]
C0220847
UMLS CUI [4,2]
C0920648
chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
Descripción

Chronic inflammation Biopsy of liver Consistent with Chronic viral hepatitis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021376
UMLS CUI [1,2]
C0193388
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0276623
hcv genotype 4.
Descripción

Hepatitis C virus genotype 4

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3532922
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
Descripción

PEGINTERFERON | Ribavirin | Combined Modality Therapy Disease Response failed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2]
C0035525
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C1704632
UMLS CUI [3,3]
C0231175
females who are either pregnant, breast-feeding or not using birth control and are sexually active.
Descripción

Pregnancy | Breast Feeding | Gender Sexually active Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0332268
males whose female partners are pregnant.
Descripción

Gender Partner Female pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
Descripción

Liver disease Cause | Hepatitis, Autoimmune | Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0241910
UMLS CUI [3]
C4075847
patients co-infected with hepatitis a virus, hepatitis b virus or hepatitis d virus.
Descripción

Hepatitis A Virus Coinfection | HBV coinfection | Hepatitis Delta Virus Coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2242656
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
patients with a history of alcoholism or with an alcohol consumption of >40 grams per day.
Descripción

Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
Descripción

Hemoglobinopathies | Cooley's anemia | Anemia, Sickle Cell

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0002875
UMLS CUI [3]
C0002895
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.
Descripción

Comorbidity Excludes Disease Response Evaluation | Comorbidity Protocol Compliance Unlikely

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1704632
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0750558
history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.
Descripción

Hypersensitivity Nitazoxanide Oral Tablet Excipient | Hypersensitivity peginterferon alfa-2a Injectable Solution Excipient | Hypersensitivity Ribavirin Tablet Excipient | Intolerance to Nitazoxanide Oral Tablet Excipient | Intolerance to peginterferon alfa-2a Injectable Solution Excipient | Intolerance to Ribavirin Tablet Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1378220
UMLS CUI [1,3]
C0015237
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1253295
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0035525
UMLS CUI [3,3]
C0039225
UMLS CUI [3,4]
C0015237
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C1378220
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C1253295
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0035525
UMLS CUI [6,3]
C0039225
UMLS CUI [6,4]
C0015237
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Similar models

Eligibility Chronic Hepatitis C NCT00421434

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length Evidence of | Hepatitis C Antibodies Enzyme Immunoassay Positive | Reverse Transcriptase Polymerase Chain Reaction Quantitative Positive | Hepatitis C virus RNA amplification
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 [1,1])
C0872146 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0166049 (UMLS CUI [2,1])
C0086231 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0599161 (UMLS CUI [3,1])
C0392762 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0220847 (UMLS CUI [4,1])
C0920648 (UMLS CUI [4,2])
Chronic inflammation Biopsy of liver Consistent with Chronic viral hepatitis
Item
chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
boolean
C0021376 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0276623 (UMLS CUI [1,4])
Hepatitis C virus genotype 4
Item
hcv genotype 4.
boolean
C3532922 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
PEGINTERFERON | Ribavirin | Combined Modality Therapy Disease Response failed
Item
patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy.
boolean
C0982327 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Gender Sexually active Contraceptive methods Lacking
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])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Gender Partner Female pregnancy
Item
males whose female partners are pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Liver disease Cause | Hepatitis, Autoimmune | Decompensated liver disease
Item
patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease).
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0241910 (UMLS CUI [2])
C4075847 (UMLS CUI [3])
Hepatitis A Virus Coinfection | HBV coinfection | Hepatitis Delta Virus Coinfection
Item
patients co-infected with hepatitis a virus, hepatitis b virus or hepatitis d virus.
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
Alcoholic Intoxication, Chronic | Alcohol consumption Grams per day
Item
patients with a history of alcoholism or with an alcohol consumption of >40 grams per day.
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Hemoglobinopathies | Cooley's anemia | Anemia, Sickle Cell
Item
patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).
boolean
C0019045 (UMLS CUI [1])
C0002875 (UMLS CUI [2])
C0002895 (UMLS CUI [3])
Comorbidity Excludes Disease Response Evaluation | Comorbidity Protocol Compliance Unlikely
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 [1,1])
C0332196 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0750558 (UMLS CUI [2,3])
Hypersensitivity Nitazoxanide Oral Tablet Excipient | Hypersensitivity peginterferon alfa-2a Injectable Solution Excipient | Hypersensitivity Ribavirin Tablet Excipient | Intolerance to Nitazoxanide Oral Tablet Excipient | Intolerance to peginterferon alfa-2a Injectable Solution Excipient | Intolerance to Ribavirin Tablet Excipient
Item
history of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets.
boolean
C0020517 (UMLS CUI [1,1])
C1378220 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1253295 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0039225 (UMLS CUI [3,3])
C0015237 (UMLS CUI [3,4])
C1744706 (UMLS CUI [4,1])
C1378220 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C1744706 (UMLS CUI [5,1])
C1253295 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C0035525 (UMLS CUI [6,2])
C0039225 (UMLS CUI [6,3])
C0015237 (UMLS CUI [6,4])
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