ID

17534

Beschrijving

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).; ODM derived from: https://clinicaltrials.gov/show/NCT00077649

Link

https://clinicaltrials.gov/show/NCT00077649

Trefwoorden

  1. 22-09-16 22-09-16 -
Geüploaded op

22 september 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT00077649

Eligibility Hepatitis C, Chronic NCT00077649

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients >=18 years of age;
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
body weight >85kg (187lbs);
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
chc (genotype 1);
Beschrijving

Chronic hepatitis C genotype 1

Datatype

boolean

Alias
UMLS CUI [1]
C4049392
liver biopsy (in <24 calendar months of first dose), with results consistent with chc infection;
Beschrijving

Biopsy of liver | Results Consistent with Chronic Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0524910
use of 2 forms of contraception during study and 6 months after the study in both men and women.
Beschrijving

Contraceptive methods Quantity | Gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0079399
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male partners of women who are pregnant;
Beschrijving

Partners Male Pregnant Women

Datatype

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0086582
UMLS CUI [1,3]
C0033011
conditions associated with decompensated liver disease;
Beschrijving

Condition Associated with Decompensated liver disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C4075847
other forms of liver disease, including liver cancer;
Beschrijving

Liver diseases | Malignant neoplasm of liver

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0345904
human immunodeficiency virus infection;
Beschrijving

HIV Infections

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Beschrijving

interferon | Ribavirin | ribavirin amidine | Ribavirin Analogue | Amantadine

Datatype

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2]
C0035525
UMLS CUI [3]
C0073221
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0243071
UMLS CUI [5]
C0002403

Similar models

Eligibility Hepatitis C, Chronic NCT00077649

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients >=18 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body Weight
Item
body weight >85kg (187lbs);
boolean
C0005910 (UMLS CUI [1])
Chronic hepatitis C genotype 1
Item
chc (genotype 1);
boolean
C4049392 (UMLS CUI [1])
Biopsy of liver | Results Consistent with Chronic Hepatitis C
Item
liver biopsy (in <24 calendar months of first dose), with results consistent with chc infection;
boolean
C0193388 (UMLS CUI [1])
C1254595 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Contraceptive methods Quantity | Gender
Item
use of 2 forms of contraception during study and 6 months after the study in both men and women.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Partners Male Pregnant Women
Item
male partners of women who are pregnant;
boolean
C0682323 (UMLS CUI [1,1])
C0086582 (UMLS CUI [1,2])
C0033011 (UMLS CUI [1,3])
Condition Associated with Decompensated liver disease
Item
conditions associated with decompensated liver disease;
boolean
C0348080 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C4075847 (UMLS CUI [1,3])
Liver diseases | Malignant neoplasm of liver
Item
other forms of liver disease, including liver cancer;
boolean
C0023895 (UMLS CUI [1])
C0345904 (UMLS CUI [2])
HIV Infections
Item
human immunodeficiency virus infection;
boolean
C0019693 (UMLS CUI [1])
interferon | Ribavirin | ribavirin amidine | Ribavirin Analogue | Amantadine
Item
previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
boolean
C0733470 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0073221 (UMLS CUI [3])
C0035525 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C0002403 (UMLS CUI [5])

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