ID

27910

Description

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care; ODM derived from: https://clinicaltrials.gov/show/NCT01012895

Link

https://clinicaltrials.gov/show/NCT01012895

Keywords

Versions (1)
  1. 12/5/17 12/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT01012895

English

Eligibility Chronic Hepatitis C NCT01012895

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ages 18 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hcv-infected genotype 1 null responders to current standard of care
Description

Hepatitis C Virus genotype 1 | Standard of Care Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3532919
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0205269
expansion cohorts a1 and a2 are restricted to patients infected with hcv genotype 1b only.
Description

Hepatitis C Virus genotype 1b

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3495940
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of a medical condition associate with chronic liver disease other than hcv
Description

Medical condition Associated with Chronic liver disease | Exception Hepatitis C virus

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220847
history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
Description

Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis

Data type

boolean

Alias
UMLS CUI [1]
C0333106
UMLS CUI [2]
C0019151
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0012798
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0034115
history of cancer within 5 years of enrollment
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
history of gastrointestinal disease or surgical procedure (except cholecystectomy)
Description

Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Exception Cholecystectomy

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0524722
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0008320
history of clinically significant cardiac disease
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
history of glucose-6-phosphate dehydrogenase (g6pd) deficiency
Description

Deficiency of glucose-6-phosphate dehydrogenase

Data type

boolean

Alias
UMLS CUI [1]
C2939465
documented cirrhosis within 12 months prior to dosing
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
positive for human immunodeficiency virus (hiv) or hepatitis b virus (hbv)
Description

HIV Seropositivity | Hepatitis B virus test positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Chronic Hepatitis C NCT01012895

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects ages 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Virus genotype 1 | Standard of Care Unresponsive to Treatment
Item
hcv-infected genotype 1 null responders to current standard of care
boolean
C0019196 (UMLS CUI [1,1])
C3532919 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Hepatitis C Virus genotype 1b
Item
expansion cohorts a1 and a2 are restricted to patients infected with hcv genotype 1b only.
boolean
C0019196 (UMLS CUI [1,1])
C3495940 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Associated with Chronic liver disease | Exception Hepatitis C virus
Item
evidence of a medical condition associate with chronic liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis
Item
history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0003962 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0012798 (UMLS CUI [3,3])
C0003962 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0034115 (UMLS CUI [4,3])
Malignant Neoplasms
Item
history of cancer within 5 years of enrollment
boolean
C0006826 (UMLS CUI [1])
Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Exception Cholecystectomy
Item
history of gastrointestinal disease or surgical procedure (except cholecystectomy)
boolean
C0017178 (UMLS CUI [1])
C0524722 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0008320 (UMLS CUI [3,2])
Heart Disease
Item
history of clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
history of glucose-6-phosphate dehydrogenase (g6pd) deficiency
boolean
C2939465 (UMLS CUI [1])
Liver Cirrhosis
Item
documented cirrhosis within 12 months prior to dosing
boolean
C0023890 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B virus test positive
Item
positive for human immunodeficiency virus (hiv) or hepatitis b virus (hbv)
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
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