Information:
Fel:
ID
29733
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00561015
Nyckelord
Versioner (1)
- 2018-04-16 2018-04-16 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
16 april 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00561015
Eligibility Hepatitis C, Chronic NCT00561015
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C, Chronic NCT00561015
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0039329 (UMLS CUI [1,2])