Informationen:
Fehler:
ID
39744
Beschreibung
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1; ODM derived from: https://clinicaltrials.gov/show/NCT01994486
Link
https://clinicaltrials.gov/show/NCT01994486
Stichworte
Versionen (1)
- 15.02.20 15.02.20 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
15. 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.
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 NCT01994486
Eligibility Hepatitis C, Chronic NCT01994486
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Hepatitis C, Chronic NCT01994486
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) ≥ 18 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv rna quantifiable at screening and >1,000 iu/ml
boolean
C1272251 (UMLS CUI [1])
Therapy naive HCV
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,2])
Hepatitis C virus genotype
Item
hcv genotype 1
boolean
C1533728 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C antibody test positive | Hepatitis C RNA positive | Hepatitis virus genotyping Positive | Biopsy of liver
Item
7. confirmation of chronic hcv infection documented by either: a positive anti-hcv antibody test or positive hcv rna or positive hcv genotyping test at least 6 months prior to the baseline/day 1 visit, or a liver biopsy performed prior to the baseline/day 1 visit with evidence of chronic hcv infection
boolean
C0524910 (UMLS CUI [1])
C1277805 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C2368162 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0193388 (UMLS CUI [5])
C1277805 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
C2368162 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0193388 (UMLS CUI [5])
Criteria Any Fulfill
Item
current or prior history of any of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Illness Clinical Significance | Liver Cirrhosis | Electrocardiogram abnormal
Item
clinically-significant illness cirrhosis 2. screening ecg with clinically significant abnormalities
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
C2826293 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Alanine aminotransferase increased
Item
1. alt > 10 x the upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
2. ast > 10 x uln
boolean
C0151904 (UMLS CUI [1])
Direct bilirubin increased
Item
3. direct bilirubin > 1.5 x uln
boolean
C0740434 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelets < 150,000/μl
boolean
C0032181 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
5. hba1c > 7.5%
boolean
C0474680 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. creatinine clearance (clcr) < 60 ml /min, as calculated by the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
7. hemoglobin < 11 g/dl for female subjects; < 12 g/dl for male subjects.
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
Albumin measurement
Item
8. albumin < 3.1 g/dl
boolean
C0201838 (UMLS CUI [1])
INR raised | Exception Hemophilia | Exception Anticoagulant therapy Stable | Exception Anticoagulant therapy Affecting INR | Exposure to DIRECT ACTING ANTIVIRALS HCV
Item
9. inr > 1.5 x uln unless subject has known hemophilia or is stable on an anticoagulant regimen affecting inr 4. prior exposure to any approved or experimental hcv-specific direct-acting
boolean
C0853225 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0684275 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0150457 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0150457 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525032 (UMLS CUI [4,4])
C0332157 (UMLS CUI [5,1])
C3653501 (UMLS CUI [5,2])
C0220847 (UMLS CUI [5,3])
C1705847 (UMLS CUI [2,1])
C0684275 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0150457 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0150457 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525032 (UMLS CUI [4,4])
C0332157 (UMLS CUI [5,1])
C3653501 (UMLS CUI [5,2])
C0220847 (UMLS CUI [5,3])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
5. pregnant or nursing female or male with pregnant female partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Chronic liver disease | Etiology Except HCV | Hemochromatosis | Wilson's disease | alpha 1-Antitrypsin Deficiency | Cholangitis
Item
6. chronic liver disease of a non-hcv etiology (e.g., hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
boolean
C0341439 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0018995 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0221757 (UMLS CUI [5])
C0008311 (UMLS CUI [6])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0018995 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0221757 (UMLS CUI [5])
C0008311 (UMLS CUI [6])
Hepatitis B | HIV Infection
Item
7. infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv).
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019693 (UMLS CUI [2])