ID

39730

Descrição

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2; ODM derived from: https://clinicaltrials.gov/show/NCT01728324

Link

https://clinicaltrials.gov/show/NCT01728324

Palavras-chave

Versões (1)
  1. 14/02/2020 14/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de fevereiro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01728324

Inglês

Eligibility Hepatitis C, Chronic NCT01728324

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chronic hepatitis c infection, diagnosed by positive anti-hcv antibodies and detected hcv rna at screening
Descrição

Hepatitis C, Chronic | Hepatitis C Antibodies Positive | Hepatitis C virus RNA Detected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0442726
2. hcv infection of sub-gt1b confirmed by genotypic testing at screening.
Descrição

Hepatitis C Genotype | Hepatitis virus genotyping

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C2368162
3. hcv viral load =1,000 iu/ml at randomisation.
Descrição

HCV viral load

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868902
4. patients who have never been previously treated with any other hcv treatment regimen.
Descrição

Prior Therapy Absent Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019196
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hcv infection of mixed gt (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
Descrição

Hepatitis C Genotype Mixed | Hepatitis virus genotyping

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [1,3]
C0205430
UMLS CUI [2]
C2368162
2. hcv infection of sub-gt1a, mixed gt1a/1b, or undefined gt1.
Descrição

Hepatitis C Genotype | Hepatitis C Genotype Mixed | Hepatitis C Genotype undefined

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C1533728
UMLS CUI [2,3]
C0205430
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C1533728
UMLS CUI [3,3]
C0750600
3. liver disease due to causes other than chronic hcv infection.
Descrição

Liver disease | Etiology Except Chronic Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
4. hiv infection.
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
5. hepatitis b virus infection based on presence of hbs-ag.
Descrição

Hepatitis B | Hepatitis B Surface Antigens Present

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
6. confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
Descrição

Malignant Neoplasms | Malignant Neoplasm Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
7. history of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
Descrição

DRUG ABUSE ILLICIT | Exception Marihuana | Alcoholic Intoxication, Chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743253
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024808
UMLS CUI [3]
C0001973
8. subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
Descrição

Compliance Unwilling Precautionary procedure | Precautionary procedure Preventing Photosensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C1300317
UMLS CUI [2,1]
C1300317
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0349506
9. decompensated liver disease, or history of decompensated liver disease.
Descrição

Decompensated liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4075847
10. clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
Descrição

Cardiovascular Disease Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
11. red blood cell disorders.
Descrição

Disease Erythrocytic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0014792
12. body weight <40 kg or >125 kg.
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
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Similar models

Eligibility Hepatitis C, Chronic NCT01728324

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C Antibodies Positive | Hepatitis C virus RNA Detected
Item
1. chronic hepatitis c infection, diagnosed by positive anti-hcv antibodies and detected hcv rna at screening
boolean
C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0442726 (UMLS CUI [3,2])
Hepatitis C Genotype | Hepatitis virus genotyping
Item
2. hcv infection of sub-gt1b confirmed by genotypic testing at screening.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C2368162 (UMLS CUI [2])
HCV viral load
Item
3. hcv viral load =1,000 iu/ml at randomisation.
boolean
C1868902 (UMLS CUI [1])
Prior Therapy Absent Hepatitis C
Item
4. patients who have never been previously treated with any other hcv treatment regimen.
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype Mixed | Hepatitis virus genotyping
Item
1. hcv infection of mixed gt (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C2368162 (UMLS CUI [2])
Hepatitis C Genotype | Hepatitis C Genotype Mixed | Hepatitis C Genotype undefined
Item
2. hcv infection of sub-gt1a, mixed gt1a/1b, or undefined gt1.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
C0019196 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
C0750600 (UMLS CUI [3,3])
Liver disease | Etiology Except Chronic Hepatitis C
Item
3. liver disease due to causes other than chronic hcv infection.
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
HIV Infection
Item
4. hiv infection.
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis B Surface Antigens Present
Item
5. hepatitis b virus infection based on presence of hbs-ag.
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Malignant Neoplasms | Malignant Neoplasm Suspected
Item
6. confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
DRUG ABUSE ILLICIT | Exception Marihuana | Alcoholic Intoxication, Chronic
Item
7. history of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
boolean
C0743253 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024808 (UMLS CUI [2,2])
C0001973 (UMLS CUI [3])
Compliance Unwilling Precautionary procedure | Precautionary procedure Preventing Photosensitivity
Item
8. subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
boolean
C1321605 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1300317 (UMLS CUI [1,3])
C1300317 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0349506 (UMLS CUI [2,3])
Decompensated liver disease
Item
9. decompensated liver disease, or history of decompensated liver disease.
boolean
C4075847 (UMLS CUI [1])
Cardiovascular Disease Unstable
Item
10. clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Disease Erythrocytic
Item
11. red blood cell disorders.
boolean
C0012634 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
Body Weight
Item
12. body weight <40 kg or >125 kg.
boolean
C0005910 (UMLS CUI [1])
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