ID

39687

Beschreibung

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009); ODM derived from: https://clinicaltrials.gov/show/NCT00704405

Link

https://clinicaltrials.gov/show/NCT00704405

Stichworte

Versionen (1)
  1. 10.02.20 10.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Februar 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hepatitis C, Chronic NCT00704405

Englisch

Eligibility Hepatitis C, Chronic NCT00704405

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
has chronic hcv genotype 1 infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
is treatment-experienced
Beschreibung

Therapy Experience

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
for the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
Beschreibung

Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver Cirrhosis Biopsy of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0193388
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0193388
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
has not tolerated previous course peg-ifn and rbv
Beschreibung

Intolerance to PEGINTERFERON/RIBAVIRIN Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1875630
UMLS CUI [1,3]
C0205156
is unlikely to tolerate at least 24 weeks of continuous therapy with peg-ifn and rbv
Beschreibung

Intolerance to PEGINTERFERON/RIBAVIRIN Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1875630
UMLS CUI [1,3]
C0449238
is co-infected with human immunodeficiency virus (hiv) and/or hepatitis b
Beschreibung

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
consumes excessive amounts of alcohol
Beschreibung

Alcohol intake above recommended sensible limits

Datentyp

boolean

Alias
UMLS CUI [1]
C0560219
has a history of drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
if female, participant is pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
has been in a clinical trail with an investigational drug in the last 30 days
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
has used ifn/peg-ifn and rbv in the last 3 months
Beschreibung

Use of Interferon Recent | Use of PEGINTERFERON Recent | Use of Ribavirin Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C3652465
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0982327
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0035525
UMLS CUI [3,3]
C0332185
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT00704405

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
has chronic hcv genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy Experience
Item
is treatment-experienced
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
Liver Cirrhosis Absent Biopsy of liver | Liver carcinoma Absent Biopsy of liver | Liver Cirrhosis Biopsy of liver
Item
for the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Intolerance to PEGINTERFERON/RIBAVIRIN Previous
Item
has not tolerated previous course peg-ifn and rbv
boolean
C1744706 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Intolerance to PEGINTERFERON/RIBAVIRIN Duration
Item
is unlikely to tolerate at least 24 weeks of continuous therapy with peg-ifn and rbv
boolean
C1744706 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
is co-infected with human immunodeficiency virus (hiv) and/or hepatitis b
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Alcohol intake above recommended sensible limits
Item
consumes excessive amounts of alcohol
boolean
C0560219 (UMLS CUI [1])
Substance Use Disorders
Item
has a history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
if female, participant is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
has been in a clinical trail with an investigational drug in the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Use of Interferon Recent | Use of PEGINTERFERON Recent | Use of Ribavirin Recent
Item
has used ifn/peg-ifn and rbv in the last 3 months
boolean
C1524063 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video