ID

35258

Description

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02243280

Lien

https://clinicaltrials.gov/show/NCT02243280

Mots-clés

Versions (1)
  1. 25/02/2019 25/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

25 février 2019

DOI

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Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Chronic Hepatitis C NCT02243280

Anglais

Eligibility Chronic Hepatitis C NCT02243280

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female between 18 and 70 years of age, inclusive, at time of screening.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. screening laboratory result indicating hcv gt1, gt4, gt 5, or gt6 infection.
Description

Hepatitis C Genotype

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
3. chronic hcv infection.
Description

Hepatitis C, Chronic

Type de données

boolean

Alias
UMLS CUI [1]
C0524910
4. subject must be either hcv treatment-naïve or combination of pegylated-interferon ribavirin experienced.
Description

Therapy naive Hepatitis C virus | PEGINTERFERON/RIBAVIRIN

Type de données

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0220847
UMLS CUI [2]
C1875630
5. subjects must be documented as non-cirrhotic or cirrhotic.
Description

Study Subject Non-cirrhotic | Study Subject Cirrhotic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0439687
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0439686
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of severe, life-threatening or other significant sensitivity to any drug.
Description

Drug Allergy Severe | Drug Allergy Life Threatening | Drug Allergy Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C2826244
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C0750502
2. female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Description

Pregnancy | Pregnancy, Planned | Breast Feeding | Gender Partner Pregnancy | Gender Partner Planned Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0032961
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0032992
3. recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Description

Substance Use Disorders Exclude Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
4. positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
Description

Hepatitis B surface antigen positive | HIV antibody positive

Type de données

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
5. hcv genotype performed during screening indicating co-infection with more than one hcv genotype.
Description

HCV coinfection Genotype Quantity | Hepatitis C virus genotype determination

Type de données

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0017431
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C1533728
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Similar models

Eligibility Chronic Hepatitis C NCT02243280

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female between 18 and 70 years of age, inclusive, at time of screening.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Genotype
Item
2. screening laboratory result indicating hcv gt1, gt4, gt 5, or gt6 infection.
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
Hepatitis C, Chronic
Item
3. chronic hcv infection.
boolean
C0524910 (UMLS CUI [1])
Therapy naive Hepatitis C virus | PEGINTERFERON/RIBAVIRIN
Item
4. subject must be either hcv treatment-naïve or combination of pegylated-interferon ribavirin experienced.
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C1875630 (UMLS CUI [2])
Study Subject Non-cirrhotic | Study Subject Cirrhotic
Item
5. subjects must be documented as non-cirrhotic or cirrhotic.
boolean
C0681850 (UMLS CUI [1,1])
C0439687 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0439686 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Severe | Drug Allergy Life Threatening | Drug Allergy Significant
Item
1. history of severe, life-threatening or other significant sensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
Pregnancy | Pregnancy, Planned | Breast Feeding | Gender Partner Pregnancy | Gender Partner Planned Pregnancy
Item
2. female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0032961 (UMLS CUI [4,3])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0032992 (UMLS CUI [5,3])
Substance Use Disorders Exclude Protocol Compliance
Item
3. recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
boolean
C0038586 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Hepatitis B surface antigen positive | HIV antibody positive
Item
4. positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
HCV coinfection Genotype Quantity | Hepatitis C virus genotype determination
Item
5. hcv genotype performed during screening indicating co-infection with more than one hcv genotype.
boolean
C1698259 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1533728 (UMLS CUI [2])
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