ID

39646

Beschrijving

A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01567735

Link

https://clinicaltrials.gov/show/NCT01567735

Trefwoorden

Versies (1)
  1. 08-02-20 08-02-20 -
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See clinicaltrials.gov

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8 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01567735

Engels

Eligibility Hepatitis C NCT01567735

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
genotype 4 hepatitis c virus (hcv) infection (confirmed at screening)
Beschrijving

Hepatitis C Genotype

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
plasma hcv ribonucleic acid (rna) of >10,000 iu/ml at screening
Beschrijving

Hepatitis C virus RNA assay Plasma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0032105
participants should be either treatment-naïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response
Beschrijving

Therapy naive | Therapy Experience | Therapy non-responder | Recurrent disease | Response Previous

Datatype

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0596545
UMLS CUI [3]
C0919875
UMLS CUI [4]
C0277556
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0205156
participants must have voluntarily signed an informed consent form (icf) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. to participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate icf for this component (where local regulations permit). refusal to give consent for this component does not exclude a participant from participation in the core study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
participants must have had a liver biopsy within 3 years prior to screening (or between screening and baseline visit) with histology consistent with chronic hcv infection
Beschrijving

Biopsy of liver | Histology Consistent with Chronic Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0524910
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
has an infection/co-infection with non-genotype 4 hcv
Beschrijving

Hepatitis C | HCV coinfection | Exception Hepatitis C virus genotype

Datatype

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C1698259
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1533728
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening).
Beschrijving

Coinfection HIV-1 | Coinfection HIV-2 | HIV-1 Antibodies Positive | HIV-2 Antibodies Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0275524
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0275524
UMLS CUI [2,2]
C0019707
UMLS CUI [3,1]
C1254603
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C1255639
UMLS CUI [4,2]
C1514241
has any of the following laboratory abnormalities:
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
1. platelet count <90,000/mm3;
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
2. absolute neutrophil count (anc) <1500 cells/mm3 (blacks: <1200 cells/mm3);
Beschrijving

Absolute neutrophil count | Blacks

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005680
3. hemoglobin <12 g/dl for women and <13 g/dl for men;
Beschrijving

Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
4. creatinine >1.5 mg/dl;
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
5. alt and/or ast >10 x upper limit of normal (uln);
Beschrijving

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
6. total serum bilirubin >1.5 x uln;
Beschrijving

SERUM TOTAL BILIRUBIN ELEVATED

Datatype

boolean

Alias
UMLS CUI [1]
C0595866
7. alpha-fetoprotein [afp] >50 ng/ml;
Beschrijving

Alpha one fetoprotein measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201539
8. albumin plasma concentration <3.5 g/dl;
Beschrijving

Measurement of albumin in plasma

Datatype

boolean

Alias
UMLS CUI [1]
C3525688
9. prothrombin time (pt) expressed as international normalized ratio (inr) >1.5. note: retesting of abnormal laboratory values that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.
Beschrijving

Prothrombin time assay | International Normalized Ratio

Datatype

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
used disallowed concomitant therapy
Beschrijving

Therapeutic procedure Illicit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
Beschrijving

Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C1394798
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
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Similar models

Eligibility Hepatitis C NCT01567735

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype
Item
genotype 4 hepatitis c virus (hcv) infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay Plasma
Item
plasma hcv ribonucleic acid (rna) of >10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1,1])
C0032105 (UMLS CUI [1,2])
Therapy naive | Therapy Experience | Therapy non-responder | Recurrent disease | Response Previous
Item
participants should be either treatment-naïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response
boolean
C0919936 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0596545 (UMLS CUI [2,2])
C0919875 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C1704632 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Informed Consent
Item
participants must have voluntarily signed an informed consent form (icf) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. to participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate icf for this component (where local regulations permit). refusal to give consent for this component does not exclude a participant from participation in the core study.
boolean
C0021430 (UMLS CUI [1])
Biopsy of liver | Histology Consistent with Chronic Hepatitis C
Item
participants must have had a liver biopsy within 3 years prior to screening (or between screening and baseline visit) with histology consistent with chronic hcv infection
boolean
C0193388 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | HCV coinfection | Exception Hepatitis C virus genotype
Item
has an infection/co-infection with non-genotype 4 hcv
boolean
C0019196 (UMLS CUI [1])
C1698259 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
Coinfection HIV-1 | Coinfection HIV-2 | HIV-1 Antibodies Positive | HIV-2 Antibodies Positive
Item
has a co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening).
boolean
C0275524 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0275524 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C1254603 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C1255639 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Laboratory test result abnormal
Item
has any of the following laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Platelet Count measurement
Item
1. platelet count <90,000/mm3;
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count | Blacks
Item
2. absolute neutrophil count (anc) <1500 cells/mm3 (blacks: <1200 cells/mm3);
boolean
C0948762 (UMLS CUI [1])
C0005680 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
3. hemoglobin <12 g/dl for women and <13 g/dl for men;
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum
Item
4. creatinine >1.5 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
5. alt and/or ast >10 x upper limit of normal (uln);
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
SERUM TOTAL BILIRUBIN ELEVATED
Item
6. total serum bilirubin >1.5 x uln;
boolean
C0595866 (UMLS CUI [1])
Alpha one fetoprotein measurement
Item
7. alpha-fetoprotein [afp] >50 ng/ml;
boolean
C0201539 (UMLS CUI [1])
Measurement of albumin in plasma
Item
8. albumin plasma concentration <3.5 g/dl;
boolean
C3525688 (UMLS CUI [1])
Prothrombin time assay | International Normalized Ratio
Item
9. prothrombin time (pt) expressed as international normalized ratio (inr) >1.5. note: retesting of abnormal laboratory values that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility.
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Therapeutic procedure Illicit
Item
used disallowed concomitant therapy
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
Hepatic decompensation | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
has evidence of 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])
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