ID

35256

Beschrijving

A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02068222

Link

https://clinicaltrials.gov/show/NCT02068222

Trefwoorden

Versies (1)
  1. 25-02-19 25-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Chronic Hepatitis C NCT02068222

Engels

Eligibility Chronic Hepatitis C NCT02068222

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (of non-child bearing potential) between 18 and 70 years of age with body mass index ≥18 to <38 kg/m2.
Beschrijving

Gender | Female infertility | Age | Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3]
C0001779
UMLS CUI [4]
C1305855
chronic hcv genotype 3 infection prior to study enrollment and has never received antiviral treatment for hcv.
Beschrijving

Chronic Hepatitis C Genotype | Antiviral Therapy Absent Hepatitis C virus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
subject has plasma hcv rna level > 10,000 iu/ml at screening.
Beschrijving

Plasma Hepatitis C virus RNA assay

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032105
UMLS CUI [1,2]
C1272251
sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
Beschrijving

Gender Sexually active Infertility | Partner Male | Gender Sexually active Contraceptive methods Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0021359
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0086582
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
Beschrijving

Hepatitis B surface antigen positive | HIV antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0920548
prior therapy for the treatment of hcv.
Beschrijving

Prior Therapy Hepatitis C virus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0220847
any current or past clinical evidence of cirrhosis.
Beschrijving

Liver Cirrhosis | Liver Cirrhosis In the past

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C1444637
any cause of liver disease other than chronic hcv-infection.
Beschrijving

Liver disease Cause Any | Exception Chronic Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
hcv genotype co-infection with any other hcv genotype.
Beschrijving

HCV coinfection Genotype | Hepatitis C virus genotype Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0017431
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0205394
use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
Beschrijving

Pharmaceutical Preparations Contraindicated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
Terug naar het begin van de pagina

Similar models

Eligibility Chronic Hepatitis C NCT02068222

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Age | Body mass index
Item
male or female (of non-child bearing potential) between 18 and 70 years of age with body mass index ≥18 to <38 kg/m2.
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1305855 (UMLS CUI [4])
Chronic Hepatitis C Genotype | Antiviral Therapy Absent Hepatitis C virus
Item
chronic hcv genotype 3 infection prior to study enrollment and has never received antiviral treatment for hcv.
boolean
C0524910 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Plasma Hepatitis C virus RNA assay
Item
subject has plasma hcv rna level > 10,000 iu/ml at screening.
boolean
C0032105 (UMLS CUI [1,1])
C1272251 (UMLS CUI [1,2])
Gender Sexually active Infertility | Partner Male | Gender Sexually active Contraceptive methods Quantity
Item
sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0021359 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0086582 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Severe | Drug Allergy Life Threatening | Drug Allergy Significant
Item
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])
Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab).
boolean
C0149709 (UMLS CUI [1])
C0920548 (UMLS CUI [2])
Prior Therapy Hepatitis C virus
Item
prior therapy for the treatment of hcv.
boolean
C1514463 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
Liver Cirrhosis | Liver Cirrhosis In the past
Item
any current or past clinical evidence of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Liver disease Cause Any | Exception Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv-infection.
boolean
C0023895 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
HCV coinfection Genotype | Hepatitis C virus genotype Other
Item
hcv genotype co-infection with any other hcv genotype.
boolean
C1698259 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pharmaceutical Preparations Contraindicated
Item
use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial