ID

39724

Descripción

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01528735

Link

https://clinicaltrials.gov/show/NCT01528735

Palabras clave

Versiones (1)
  1. 12/2/20 12/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01528735

Inglés

Eligibility Hepatitis C, Chronic NCT01528735

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c, diagnosed by positive anti-hepatitis c virus(hcv) antibodies and detected hcv ribonucleic acid(rna) at screening in addition to:
Descripción

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

Tipo de datos

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
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
Descripción

Hepatitis C Antibodies Positive Timespan | Hepatitis C virus RNA Detected Timespan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C0442726
UMLS CUI [2,3]
C0872291
2. liver biopsy consistent with chronic hcv infection.
Descripción

Biopsy of liver Consistent with Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
hcv infection of genotype 1 confirmed by genotypic testing at screening
Descripción

Hepatitis C Genotype | Hepatitis virus genotyping

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C2368162
therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
Descripción

Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Antiviral Agents Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003451
UMLS CUI [4,2]
C0332197
immunomodulatory drug for acute or chronic hcv infection.
Descripción

Immunomodulatory agent Hepatitis C | Immunomodulatory agent Chronic Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005525
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0524910
plasma hcv rna = 100,000 iu/ml at screening
Descripción

Hepatitis C virus RNA assay Plasma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis c infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
Descripción

Hepatitis C Genotype Mixed | Hepatitis virus genotyping

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C4272868
UMLS CUI [1,3]
C0205430
UMLS CUI [2]
C2368162
human immunodeficiency virus (hiv) co-infection
Descripción

Human immunodeficiency virus (HIV) coinfection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4062778
decompensated liver disease, or history of decompensated liver disease
Descripción

Decompensated liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075847
body weight < 40 or > 125 kg at screening
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
hemoglobin <12.0g/dl for women and <13.0g/dl for men at screening
Descripción

Hemoglobin measurement | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
white blood cell count <3000 cells/mm3 at screening
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count < 1,500 cells/mm3 at screening
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 90,000 /mm3 at screening
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine > 1.5xupper limit of normal range(uln) or creatinine clearance =50 ml/min at screening
Descripción

Serum creatinine raised | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0373595
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Similar models

Eligibility Hepatitis C, Chronic NCT01528735

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C Antibodies Positive | Hepatitis C virus RNA Detected
Item
chronic hepatitis c, diagnosed by positive anti-hepatitis c virus(hcv) antibodies and detected hcv ribonucleic acid(rna) at screening in addition to:
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 Antibodies Positive Timespan | Hepatitis C virus RNA Detected Timespan
Item
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
boolean
C0166049 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0369335 (UMLS CUI [2,1])
C0442726 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
2. liver biopsy consistent with chronic hcv infection.
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Hepatitis C Genotype | Hepatitis virus genotyping
Item
hcv infection of genotype 1 confirmed by genotypic testing at screening
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C2368162 (UMLS CUI [2])
Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Antiviral Agents Absent
Item
therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
boolean
C3652465 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003451 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Immunomodulatory agent Hepatitis C | Immunomodulatory agent Chronic Hepatitis C
Item
immunomodulatory drug for acute or chronic hcv infection.
boolean
C0005525 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hepatitis C virus RNA assay Plasma
Item
plasma hcv rna = 100,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype Mixed | Hepatitis virus genotyping
Item
hepatitis c infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
boolean
C0019196 (UMLS CUI [1,1])
C4272868 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C2368162 (UMLS CUI [2])
Human immunodeficiency virus (HIV) coinfection
Item
human immunodeficiency virus (hiv) co-infection
boolean
C4062778 (UMLS CUI [1])
Decompensated liver disease
Item
decompensated liver disease, or history of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Body Weight
Item
body weight < 40 or > 125 kg at screening
boolean
C0005910 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hemoglobin <12.0g/dl for women and <13.0g/dl for men at screening
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure
Item
white blood cell count <3000 cells/mm3 at screening
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count < 1,500 cells/mm3 at screening
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 90,000 /mm3 at screening
boolean
C0032181 (UMLS CUI [1])
Serum creatinine raised | Creatinine clearance measurement
Item
serum creatinine > 1.5xupper limit of normal range(uln) or creatinine clearance =50 ml/min at screening
boolean
C0700225 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
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