ID

39703

Beschreibung

A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR); ODM derived from: https://clinicaltrials.gov/show/NCT01278134

Link

https://clinicaltrials.gov/show/NCT01278134

Stichworte

Versionen (1)
  1. 10.02.20 10.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01278134

Englisch

Eligibility Hepatitis C, Chronic NCT01278134

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patient, >/= 18 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hepatitis c of >/= 6 months duration at screening
Beschreibung

Chronic Hepatitis C Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0449238
hcv genotype 1 and quantifiable hcv rna at screening (roche cobas taqman hcv test)
Beschreibung

Hepatitis C Genotype | Hepatitis C RNA Quantification Test | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C1256156
UMLS CUI [3]
C3846158
naïve for treatment with interferon (pegylated or non-pegylated)
Beschreibung

PEGINTERFERON Absent | Interferon Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
body mass index (bmi) 18-35 inclusive, minimum weight 45 kg
Beschreibung

Body mass index | Body Weight Minimum

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C1524031
females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception
Beschreibung

Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Hormonal contraception Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C2985296
UMLS CUI [4,2]
C0332196
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women and males with female partners who are pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0006147
decompensated liver disease or impaired liver function
Beschreibung

Decompensated liver disease | Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0086565
cirrhosis or incomplete/transition to cirrhosis
Beschreibung

Liver Cirrhosis | Liver Cirrhosis Incomplete | Transition Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205257
UMLS CUI [3,1]
C2700061
UMLS CUI [3,2]
C0023890
non-hepatitis c chronic liver disease
Beschreibung

Chronic liver disease | Exception Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
hepatitis b or hiv infection
Beschreibung

Hepatitis B | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019693
history of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
Beschreibung

Neoplastic disease | Exception Skin carcinoma Localized | Exception Carcinoma in situ of skin

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C0392752
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0154073
history of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
Beschreibung

Kidney Disease Pre-existing | Exception Nephrolithiasis | Heart Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0392525
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
history of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted
Beschreibung

Substance Use Disorders | Alcohol consumption U/day | Exception Use of Cannabinoids

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0006864
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Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT01278134

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patient, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Duration
Item
chronic hepatitis c of >/= 6 months duration at screening
boolean
C0524910 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis C Genotype | Hepatitis C RNA Quantification Test | Other Coding
Item
hcv genotype 1 and quantifiable hcv rna at screening (roche cobas taqman hcv test)
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1256156 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
PEGINTERFERON Absent | Interferon Absent
Item
naïve for treatment with interferon (pegylated or non-pegylated)
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Body mass index | Body Weight Minimum
Item
body mass index (bmi) 18-35 inclusive, minimum weight 45 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Hormonal contraception Excluded
Item
females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2985296 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding
Item
pregnant or lactating women and males with female partners who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0006147 (UMLS CUI [4,3])
Decompensated liver disease | Liver Dysfunction
Item
decompensated liver disease or impaired liver function
boolean
C4075847 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Liver Cirrhosis | Liver Cirrhosis Incomplete | Transition Liver Cirrhosis
Item
cirrhosis or incomplete/transition to cirrhosis
boolean
C0023890 (UMLS CUI [1])
C0023890 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C2700061 (UMLS CUI [3,1])
C0023890 (UMLS CUI [3,2])
Chronic liver disease | Exception Hepatitis C
Item
non-hepatitis c chronic liver disease
boolean
C0341439 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Hepatitis B | HIV Infection
Item
hepatitis b or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Neoplastic disease | Exception Skin carcinoma Localized | Exception Carcinoma in situ of skin
Item
history of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
boolean
C1882062 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0154073 (UMLS CUI [3,2])
Kidney Disease Pre-existing | Exception Nephrolithiasis | Heart Disease Severe
Item
history of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
boolean
C0022658 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0392525 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Substance Use Disorders | Alcohol consumption U/day | Exception Use of Cannabinoids
Item
history of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0006864 (UMLS CUI [3,3])
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