ID

39687

Description

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009); ODM derived from: https://clinicaltrials.gov/show/NCT00704405

Link

https://clinicaltrials.gov/show/NCT00704405

Keywords

Versions (1)
  1. 2/10/20 2/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00704405

English

Eligibility Hepatitis C, Chronic NCT00704405

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has chronic hcv genotype 1 infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
is treatment-experienced
Description

Therapy Experience

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
for the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
Description

Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver Cirrhosis Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0193388
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has not tolerated previous course peg-ifn and rbv
Description

Intolerance to PEGINTERFERON/RIBAVIRIN Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1875630
UMLS CUI [1,3]
C0205156
is unlikely to tolerate at least 24 weeks of continuous therapy with peg-ifn and rbv
Description

Intolerance to PEGINTERFERON/RIBAVIRIN Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1875630
UMLS CUI [1,3]
C0449238
is co-infected with human immunodeficiency virus (hiv) and/or hepatitis b
Description

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
consumes excessive amounts of alcohol
Description

Alcohol intake above recommended sensible limits

Data type

boolean

Alias
UMLS CUI [1]
C0560219
has a history of drug or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
if female, participant is pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
has been in a clinical trail with an investigational drug in the last 30 days
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
has used ifn/peg-ifn and rbv in the last 3 months
Description

Use of Interferon Recent | Use of PEGINTERFERON Recent | Use of Ribavirin Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3652465
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0982327
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0035525
UMLS CUI [3,3]
C0332185
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Similar models

Eligibility Hepatitis C, Chronic NCT00704405

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
has chronic hcv genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy Experience
Item
is treatment-experienced
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver Cirrhosis Biopsy of liver
Item
for the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Intolerance to PEGINTERFERON/RIBAVIRIN Previous
Item
has not tolerated previous course peg-ifn and rbv
boolean
C1744706 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Intolerance to PEGINTERFERON/RIBAVIRIN Duration
Item
is unlikely to tolerate at least 24 weeks of continuous therapy with peg-ifn and rbv
boolean
C1744706 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
is co-infected with human immunodeficiency virus (hiv) and/or hepatitis b
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Alcohol intake above recommended sensible limits
Item
consumes excessive amounts of alcohol
boolean
C0560219 (UMLS CUI [1])
Substance Use Disorders
Item
has a history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
if female, participant is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
has been in a clinical trail with an investigational drug in the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Use of Interferon Recent | Use of PEGINTERFERON Recent | Use of Ribavirin Recent
Item
has used ifn/peg-ifn and rbv in the last 3 months
boolean
C1524063 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
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