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ID
39726
Beschreibung
A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01591460
Link
https://clinicaltrials.gov/show/NCT01591460
Stichworte
Versionen (2)
- 13.02.20 13.02.20 -
- 20.09.21 20.09.21 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
13. Februar 2020
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01591460
Eligibility Hepatitis C, Chronic NCT01591460
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatitis C, Chronic NCT01591460
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Adult | Age
Item
adult patients >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Chronic liver disease Consistent with Chronic Hepatitis C Genotype
Item
chronic liver disease consistent with chronic hepatitis c, genotype 1 infection
boolean
C0341439 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1533728 (UMLS CUI [1,4])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C1533728 (UMLS CUI [1,4])
Serum hepatitis c viral rna quantitative
Item
serum hcv rna quantifiable at screening
boolean
C4272238 (UMLS CUI [1])
PEGINTERFERON Absent | Interferon Absent | Ribavirin Absent | DIRECT ACTING ANTIVIRALS Absent
Item
patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3653501 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3653501 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Compensated liver disease Child-Pugh Classification | Patients Liver Cirrhosis | Compensated liver disease Child-Pugh - Total Score
Item
compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score </=6)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
C3839044 (UMLS CUI [3,1])
C4055253 (UMLS CUI [3,2])
C2347612 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
C3839044 (UMLS CUI [3,1])
C4055253 (UMLS CUI [3,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Pregnancy blood test Negative
Item
negative urine or blood pregnancy test (for women of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Gender Partner Pregnancy
Item
male partners of women who are pregnant
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Antiviral Therapy Systemic | Antineoplastic Agents Systemic | Immunomodulatory therapy Systemic
Item
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment </=6 months prior to the first dose of study drug
boolean
C0280274 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1963758 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1963758 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
Investigational New Drugs
Item
any investigational drug </=6 weeks prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
Decompensated liver disease
Item
history or other evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Medical condition Associated with Chronic liver disease | Exception Chronic Hepatitis C
Item
history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
C0332281 (UMLS CUI [1,2])
C0341439 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Sign or Symptom Liver carcinoma
Item
signs or symptoms of hepatocellular carcinoma
boolean
C3540840 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,2])
HCV coinfection Genotype | Exception Hepatitis C virus genotype determination
Item
co-infection with hcv genotypes other than genotype 1
boolean
C1698259 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1148363 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Coinfection Hepatitis A | HBV coinfection | HIV coinfection
Item
co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv)
boolean
C0275524 (UMLS CUI [1,1])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
C0019159 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
C4062778 (UMLS CUI [3])
High risk of Anemia
Item
any patient with an increased risk for anemia
boolean
C0332167 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
C0002871 (UMLS CUI [1,2])
Mental Disorders, Severe
Item
history of severe psychiatric disease
boolean
C4046029 (UMLS CUI [1])
Disease Immune-mediated | Chronic lung disease | Heart Disease Severe
Item
history of immunologically mediated, chronic pulmonary, or severe cardiac disease
boolean
C0012634 (UMLS CUI [1,1])
C4330477 (UMLS CUI [1,2])
C0746102 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C4330477 (UMLS CUI [1,2])
C0746102 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Disease Poorly controlled
Item
current diseases that are not adequately controlled
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,2])