ID

40905

Descrição

An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02278419

Link

https://clinicaltrials.gov/show/NCT02278419

Palavras-chave

Versões (1)
  1. 02/06/2020 02/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de junho de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hepatitis C NCT02278419

Inglês

Eligibility Hepatitis C NCT02278419

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must have hepatitis c virus (hcv) genotype 4 infection (confirmed at screening)
Descrição

Hepatitis C Genotype

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
Descrição

Hepatitis C virus RNA assay

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1272251
in participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [ct] scan, or magnetic resonance imaging [mri]) within 6 months before baseline (day 1) to exclude hepatocellular carcinoma is required
Descrição

Liver Cirrhosis | Requirement Imaging procedure Hepatic | Ultrasonography | Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C0205054
UMLS CUI [3]
C0041618
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6,1]
C2239176
UMLS CUI [6,2]
C0332196
a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on day 1 before first dose of study drug
Descrição

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from day 1 (baseline) and continue until 30 days after the end of treatment (eot) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
Descrição

Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Contraceptive methods Quantity | Contraception, Barrier | Condom | Vaginal contraceptive diaphragm | Sexually active heterosexual activity Absent | Vasectomy | Gender Partner Vasectomy | Postmenopausal state | Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0677582
UMLS CUI [6]
C0042241
UMLS CUI [7,1]
C4272228
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C0042387
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0682323
UMLS CUI [9,3]
C0042387
UMLS CUI [10]
C0232970
UMLS CUI [11]
C0015787
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
Descrição

Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
participant has any liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
Descrição

Liver disease Independent of Hepatitis C virus | Hepatitis A | Liver disease Drug-induced | Alcohol-related liver disease | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0220847
UMLS CUI [2]
C0019159
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0458082
UMLS CUI [4]
C0810031
UMLS CUI [5]
C0241910
UMLS CUI [6]
C0018995
UMLS CUI [7]
C0019202
UMLS CUI [8]
C0221757
UMLS CUI [9]
C3241937
UMLS CUI [10]
C0008312
participant is infected/co-infected with non-genotype 4 hcv
Descrição

Hepatitis C Except Genotype Specified | HCV coinfection Except Genotype Specified

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C1148363
UMLS CUI [1,4]
C0205369
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1148363
UMLS CUI [2,4]
C0205369
participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ecg) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
Descrição

Disease Clinical Significance At risk Patient safety | Disease Interferes with Study Subject Participation Status | Disease Interferes with Completion of clinical trial | Signs and Symptoms Clinical Significance | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C0037088
UMLS CUI [4,2]
C2826293
UMLS CUI [5]
C0262926
UMLS CUI [6]
C0031809
UMLS CUI [7]
C0022885
UMLS CUI [8]
C1623258
participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
Descrição

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1880198
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C4528387
UMLS CUI [5,3]
C1458156
Voltar ao início da página

Similar models

Eligibility Hepatitis C NCT02278419

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype
Item
participant must have hepatitis c virus (hcv) genotype 4 infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
participant must have hcv ribonucleic acid (rna) greater than (>) 10,000 international unit per milliliter (iu/ml) at screening
boolean
C1272251 (UMLS CUI [1])
Liver Cirrhosis | Requirement Imaging procedure Hepatic | Ultrasonography | Computed Tomography | Magnetic Resonance Imaging | Liver carcinoma Excluded
Item
in participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [ct] scan, or magnetic resonance imaging [mri]) within 6 months before baseline (day 1) to exclude hepatocellular carcinoma is required
boolean
C0023890 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C0205054 (UMLS CUI [2,3])
C0041618 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C2239176 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative
Item
a woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on day 1 before first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Contraceptive methods Quantity | Contraception, Barrier | Condom | Vaginal contraceptive diaphragm | Sexually active heterosexual activity Absent | Vasectomy | Gender Partner Vasectomy | Postmenopausal state | Female Sterilization
Item
females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from day 1 (baseline) and continue until 30 days after the end of treatment (eot) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0004764 (UMLS CUI [4])
C0677582 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C4272228 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0042387 (UMLS CUI [8])
C0079399 (UMLS CUI [9,1])
C0682323 (UMLS CUI [9,2])
C0042387 (UMLS CUI [9,3])
C0232970 (UMLS CUI [10])
C0015787 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
boolean
C1394798 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Liver disease Independent of Hepatitis C virus | Hepatitis A | Liver disease Drug-induced | Alcohol-related liver disease | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
participant has any liver disease of non-hcv etiology. this includes, but is not limited to, acute hepatitis a, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hcv liver disease considered clinically significant by the investigator
boolean
C0023895 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0019159 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0810031 (UMLS CUI [4])
C0241910 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0019202 (UMLS CUI [7])
C0221757 (UMLS CUI [8])
C3241937 (UMLS CUI [9])
C0008312 (UMLS CUI [10])
Hepatitis C Except Genotype Specified | HCV coinfection Except Genotype Specified
Item
participant is infected/co-infected with non-genotype 4 hcv
boolean
C0019196 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C1148363 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C1698259 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1148363 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Disease Clinical Significance At risk Patient safety | Disease Interferes with Study Subject Participation Status | Disease Interferes with Completion of clinical trial | Signs and Symptoms Clinical Significance | Medical History | Physical Examination | Laboratory Procedures | Electrocardiography
Item
participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ecg) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C0037088 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0022885 (UMLS CUI [7])
C1623258 (UMLS CUI [8])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
Item
participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C4528387 (UMLS CUI [5,2])
C1458156 (UMLS CUI [5,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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