ID

29733

Description

A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00561015

Link

https://clinicaltrials.gov/show/NCT00561015

Keywords

  1. 4/16/18 4/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 16, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT00561015

Eligibility Hepatitis C, Chronic NCT00561015

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants chronically infected with genotype 2 or 3 hepatitis c virus (hcv) with amount of virus in the blood greater than 10,000 international units per milliliter (iu/ml)
Description

Chronic Hepatitis C HCV genotype determination | HCV viral load

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1868902
participants who were never treated for hepatitis c virus infection
Description

Hepatitis C untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0332155
participants without any significant lab abnormalities
Description

LABORATORY ABNORMALITIES Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C0332197
participants who agree to the use of two effective methods of contraception
Description

Contraceptive methods Quantity Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600109
participant who were judged to be in good health
Description

Good health

Data type

boolean

Alias
UMLS CUI [1]
C3813622
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who had contraindications for starting anti-hcv therapy
Description

Medical contraindication Hepatitis C Antibodies therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0166049
UMLS CUI [1,3]
C0087111
participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
Description

Liver Cirrhosis | Decompensated liver disease | Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4075847
UMLS CUI [3]
C2239176
participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis b virus
Description

HIV Infection | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
participants who have hypersensitivity to tartrazine
Description

Hypersensitivity Tartrazine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039329

Similar models

Eligibility Hepatitis C, Chronic NCT00561015

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C HCV genotype determination | HCV viral load
Item
participants chronically infected with genotype 2 or 3 hepatitis c virus (hcv) with amount of virus in the blood greater than 10,000 international units per milliliter (iu/ml)
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1868902 (UMLS CUI [2])
Hepatitis C untreated
Item
participants who were never treated for hepatitis c virus infection
boolean
C0019196 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
LABORATORY ABNORMALITIES Absent
Item
participants without any significant lab abnormalities
boolean
C1853129 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Contraceptive methods Quantity Willing
Item
participants who agree to the use of two effective methods of contraception
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Good health
Item
participant who were judged to be in good health
boolean
C3813622 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Hepatitis C Antibodies therapy
Item
participants who had contraindications for starting anti-hcv therapy
boolean
C1301624 (UMLS CUI [1,1])
C0166049 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Liver Cirrhosis | Decompensated liver disease | Liver carcinoma
Item
participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
boolean
C0023890 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
HIV Infection | Hepatitis B
Item
participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis b virus
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Tartrazine
Item
participants who have hypersensitivity to tartrazine
boolean
C0020517 (UMLS CUI [1,1])
C0039329 (UMLS CUI [1,2])

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