ID

39742

Description

A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01903954

Link

https://clinicaltrials.gov/show/NCT01903954

Keywords

Versions (1)
  1. 2/14/20 2/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 14, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01903954

English

Eligibility Hepatitis C, Chronic NCT01903954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18 to 65 years of age inclusive
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
documented chronic hepatitis c
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
treatment-naïve (no prior exposure to pegasys, copegus, or experimental hcv therapy) or treatment-experienced with current standard of care (pegasys and copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
Description

Therapy naive | Pegasys Absent | Copegus Absent | Investigational Therapy Absent Hepatitis C | Therapy Experience Standard of Care | Pegasys | Copegus | Non-responder | Partial responder | Relapse | Viral Breakthrough

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C1176430
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1170183
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0019196
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0596545
UMLS CUI [5,3]
C2936643
UMLS CUI [6]
C1176430
UMLS CUI [7]
C1170183
UMLS CUI [8]
C0919875
UMLS CUI [9]
C4285679
UMLS CUI [10]
C0035020
UMLS CUI [11]
C4053869
serum hcv rna >/= 50,000 iu/ml at screening
Description

Hepatitis C virus RNA assay Serum

Data type

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0229671
hcv antibody positive at screening
Description

Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
hcv genotype 1
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
body mass index (bmi) 18-38 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
in good health other than chronic hcv infection in the judgment of the principal investigators
Description

Good health | Exception Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
negative for hepatitis b and hiv infection
Description

Hepatitis B test negative | HIV test negative

Data type

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C0854048
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for treatment-naïve patients: any previous treatment for hcv infection
Description

Patients Therapy naive | Prior Therapy Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0019196
for treatment-experienced patients: previous treatment with an experimental therapy for hcv infection
Description

Patients Therapy Experience | Investigational Therapy Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0596545
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0019196
co-infection with hiv or hbv
Description

HIV coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
history or evidence of decompensated liver disease
Description

Decompensated liver disease

Data type

boolean

Alias
UMLS CUI [1]
C4075847
history or evidence of hepatocellular carcinoma
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
history of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
Description

Alcohol abuse | Drug Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1510472
poorly controlled diabetes mellitus
Description

Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
one or more additional known primary causes of liver disease other than hepatitis c
Description

Cause Quantity Liver disease | Exception Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
history of acute or chronic pancreatitis
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Hepatitis C, Chronic NCT01903954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18 to 65 years of age inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C, Chronic
Item
documented chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Therapy naive | Pegasys Absent | Copegus Absent | Investigational Therapy Absent Hepatitis C | Therapy Experience Standard of Care | Pegasys | Copegus | Non-responder | Partial responder | Relapse | Viral Breakthrough
Item
treatment-naïve (no prior exposure to pegasys, copegus, or experimental hcv therapy) or treatment-experienced with current standard of care (pegasys and copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
boolean
C0919936 (UMLS CUI [1])
C1176430 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1170183 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0596545 (UMLS CUI [5,2])
C2936643 (UMLS CUI [5,3])
C1176430 (UMLS CUI [6])
C1170183 (UMLS CUI [7])
C0919875 (UMLS CUI [8])
C4285679 (UMLS CUI [9])
C0035020 (UMLS CUI [10])
C4053869 (UMLS CUI [11])
Hepatitis C virus RNA assay Serum
Item
serum hcv rna >/= 50,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Hepatitis C antibody positive
Item
hcv antibody positive at screening
boolean
C0281863 (UMLS CUI [1])
Hepatitis C Genotype
Item
hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) 18-38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Good health | Exception Chronic Hepatitis C
Item
in good health other than chronic hcv infection in the judgment of the principal investigators
boolean
C3813622 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hepatitis B test negative | HIV test negative
Item
negative for hepatitis b and hiv infection
boolean
C1611173 (UMLS CUI [1])
C0854048 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patients Therapy naive | Prior Therapy Hepatitis C
Item
for treatment-naïve patients: any previous treatment for hcv infection
boolean
C0030705 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Patients Therapy Experience | Investigational Therapy Hepatitis C
Item
for treatment-experienced patients: previous treatment with an experimental therapy for hcv infection
boolean
C0030705 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
HIV coinfection | HBV coinfection
Item
co-infection with hiv or hbv
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Decompensated liver disease
Item
history or evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Liver carcinoma
Item
history or evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Alcohol abuse | Drug Dependence
Item
history of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
boolean
C0085762 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus
boolean
C0554876 (UMLS CUI [1])
Cause Quantity Liver disease | Exception Hepatitis C
Item
one or more additional known primary causes of liver disease other than hepatitis c
boolean
C0015127 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Pancreatitis | Pancreatitis, Chronic
Item
history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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