ID

41011

Beschreibung

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01485991

Link

https://clinicaltrials.gov/show/NCT01485991

Stichworte

Versionen (1)
  1. 11.06.20 11.06.20 -
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See clinicaltrials.gov

Hochgeladen am

11. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01485991

Englisch

Eligibility Hepatitis C NCT01485991

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. for patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. non-invasive staging assessments include fibroscan, mr-elastography, or fibrotest/fibrosure and must not be older than 6 months prior to screening
Beschreibung

Biopsy of liver | Fibroscan | MR Elastography | FibroTest Score Measurement | Fibrosure | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C4522043
UMLS CUI [3]
C1518156
UMLS CUI [4]
C3642160
UMLS CUI [5]
C1955263
UMLS CUI [6]
C0001779
chronicity of hepatitis c virus (hcv) infection, as confirmed by one or both of the following: presence of anti-hcv antibody and/or hcv ribonucleic acid (rna) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
Beschreibung

Hepatitis C, Chronic | Hepatitis C Antibodies Present | Hepatitis C virus RNA Present | Fibrosis Biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C0150312
UMLS CUI [4,1]
C0016059
UMLS CUI [4,2]
C0005558
genotype 1 hcv infection with plasma hcv rna of >10,000 iu/ml (both confirmed at screening)
Beschreibung

Hepatitis C Genotype | Plasma Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C1272251
patient must have had at least 1 documented previous course of treatment with peginfα-2a or peginfα-2b in combination with ribavirin (rbv) (at least 12 weeks for null responder and 20 weeks for partial responder)
Beschreibung

Course Previous Quantity | Combined Modality Therapy | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Therapy non-responder | Partial responder to therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0391001
UMLS CUI [4]
C0796545
UMLS CUI [5]
C0035525
UMLS CUI [6]
C0919875
UMLS CUI [7]
C1740822
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
Beschreibung

Hepatic decompensation | Relationship LABORATORY ABNORMALITIES | Relationship Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1853129
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0009488
infection with human immunodeficiency virus (hiv) or non genotype 1 hepatitis c
Beschreibung

HIV Infection | Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C1533728
liver disease not related to hepatitis c infection
Beschreibung

Liver diseases Independent of Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0019196
previous chronic hepatitis c treatment, other than pegifn and rbv
Beschreibung

Prior Therapy Chronic Hepatitis C | Exception PEGINTERFERON | Exception Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0524910
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0982327
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035525
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Ähnliche Modelle

Eligibility Hepatitis C NCT01485991

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Biopsy of liver | Fibroscan | MR Elastography | FibroTest Score Measurement | Fibrosure | Age
Item
patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. for patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. non-invasive staging assessments include fibroscan, mr-elastography, or fibrotest/fibrosure and must not be older than 6 months prior to screening
boolean
C0193388 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
C1518156 (UMLS CUI [3])
C3642160 (UMLS CUI [4])
C1955263 (UMLS CUI [5])
C0001779 (UMLS CUI [6])
Hepatitis C, Chronic | Hepatitis C Antibodies Present | Hepatitis C virus RNA Present | Fibrosis Biopsy
Item
chronicity of hepatitis c virus (hcv) infection, as confirmed by one or both of the following: presence of anti-hcv antibody and/or hcv ribonucleic acid (rna) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
boolean
C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0369335 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
C0016059 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Hepatitis C Genotype | Plasma Hepatitis C virus RNA assay
Item
genotype 1 hcv infection with plasma hcv rna of >10,000 iu/ml (both confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0032105 (UMLS CUI [2,1])
C1272251 (UMLS CUI [2,2])
Course Previous Quantity | Combined Modality Therapy | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Therapy non-responder | Partial responder to therapy
Item
patient must have had at least 1 documented previous course of treatment with peginfα-2a or peginfα-2b in combination with ribavirin (rbv) (at least 12 weeks for null responder and 20 weeks for partial responder)
boolean
C0750729 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0391001 (UMLS CUI [3])
C0796545 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C1740822 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Hepatic decompensation | Relationship LABORATORY ABNORMALITIES | Relationship Comorbidity
Item
hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
boolean
C1394798 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1853129 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
HIV Infection | Hepatitis C Genotype
Item
infection with human immunodeficiency virus (hiv) or non genotype 1 hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Liver diseases Independent of Hepatitis C
Item
liver disease not related to hepatitis c infection
boolean
C0023895 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Prior Therapy Chronic Hepatitis C | Exception PEGINTERFERON | Exception Ribavirin
Item
previous chronic hepatitis c treatment, other than pegifn and rbv
boolean
C1514463 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
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