ID

35990

Descripción

Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01797848

Link

https://clinicaltrials.gov/show/NCT01797848

Palabras clave

Versiones (1)
  1. 8/4/19 8/4/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de abril de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01797848

Inglés

Eligibility Hepatitis C NCT01797848

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients chronically infected with hepatitis c virus (hcv) gt 1 or 4
Descripción

Chronic Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
hcv rna viral load ≥ 10,000 iu/ml
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
naïve to prior treatment with any interferon formulation, ribavirin (rbv) or hcv direct antiviral agent
Descripción

Therapy naive Interferon Formulation | Therapy naive Ribavirin | Therapy naive Antiviral Agents HCV Direct

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C3652465
UMLS CUI [1,3]
C0524527
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0035525
UMLS CUI [3,1]
C0919936
UMLS CUI [3,2]
C0003451
UMLS CUI [3,3]
C4324239
patients with compensated cirrhosis are permitted
Descripción

Compensated cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1608426
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
infected with hcv other than gt 1 or 4
Descripción

Hepatitis C | Exception Hepatitis C virus genotype Specified

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1148363
UMLS CUI [2,3]
C0205369
evidence of decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
documented or suspected hepatocellular carcinoma (hcc) as evidenced by previously obtained imaging studies or liver biopsy
Descripción

Liver carcinoma Imaging study | Liver carcinoma Suspected Imaging study | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1881134
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1881134
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0193388
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0193388
evidence of a medical condition contributing to chronic liver disease other than hcv
Descripción

Medical condition Contributing Chronic liver disease | Exception Hepatitis C virus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1880177
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220847
history of chronic hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Descripción

Hepatitis B, Chronic | Chronic infection with HIV

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0853112
current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Descripción

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
laboratory values:
Descripción

Laboratory Results

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1254595
1. hemoglobin < 12 g/dl (females) or < 13 g/dl (males)
Descripción

Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
2. platelets < 90 x 1000000000 cells/l
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
3. absolute neutrophil count (anc) < 1.5 × 1000000000 cells/l
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
4. total bilirubin ≥ 34 µmol/l (unless due to gilbert's disease)
Descripción

Serum total bilirubin measurement | Exception Due to Gilbert Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017551
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Similar models

Eligibility Hepatitis C NCT01797848

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
patients chronically infected with hepatitis c virus (hcv) gt 1 or 4
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna viral load ≥ 10,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Therapy naive Interferon Formulation | Therapy naive Ribavirin | Therapy naive Antiviral Agents HCV Direct
Item
naïve to prior treatment with any interferon formulation, ribavirin (rbv) or hcv direct antiviral agent
boolean
C0919936 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0524527 (UMLS CUI [1,3])
C0919936 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
C0919936 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C4324239 (UMLS CUI [3,3])
Compensated cirrhosis
Item
patients with compensated cirrhosis are permitted
boolean
C1608426 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Exception Hepatitis C virus genotype Specified
Item
infected with hcv other than gt 1 or 4
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1148363 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Decompensated liver disease
Item
evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Liver carcinoma Imaging study | Liver carcinoma Suspected Imaging study | Liver carcinoma Biopsy of liver | Liver carcinoma Suspected Biopsy of liver
Item
documented or suspected hepatocellular carcinoma (hcc) as evidenced by previously obtained imaging studies or liver biopsy
boolean
C2239176 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0193388 (UMLS CUI [4,3])
Medical condition Contributing Chronic liver disease | Exception Hepatitis C virus
Item
evidence of a medical condition contributing to chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Hepatitis B, Chronic | Chronic infection with HIV
Item
history of chronic hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C0524909 (UMLS CUI [1])
C0853112 (UMLS CUI [2])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Laboratory Results
Item
laboratory values:
boolean
C1254595 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
1. hemoglobin < 12 g/dl (females) or < 13 g/dl (males)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
2. platelets < 90 x 1000000000 cells/l
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
3. absolute neutrophil count (anc) < 1.5 × 1000000000 cells/l
boolean
C0948762 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
4. total bilirubin ≥ 34 µmol/l (unless due to gilbert's disease)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
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