ID

39728

Beschreibung

ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01628094

Link

https://clinicaltrials.gov/show/NCT01628094

Stichworte

Versionen (1)
  1. 13.02.20 13.02.20 -
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See clinicaltrials.gov

Hochgeladen am

13. Februar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01628094

Englisch

Eligibility Hepatitis C, Chronic NCT01628094

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adult | Age

Datentyp

boolean

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

Chronic Hepatitis C Genotype Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [1,3]
C0449238
part 1 and part 2: naïve to treatment with interferon (pegylated or non-pegylated). patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
Beschreibung

PEGINTERFERON Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3653501
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
part 2: treatment experienced patients having a previous null response to treatment with interferon containing regimen
Beschreibung

Therapy Experience | Non-responder Interferon therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C0279030
liver biopsy or non-invasive (e.g. fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
Beschreibung

Biopsy of liver | Evaluation | Fibroscan | Liver Cirrhosis Absent | Absence Liver Cirrhosis Incomplete | Absence Transition Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C1261322
UMLS CUI [3]
C4522043
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0023890
UMLS CUI [5,3]
C0205257
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C2700061
UMLS CUI [6,3]
C0023890
body mass index (bmi) 18 to 35 kg/m2 inclusive and body weight >/= 45 kg
Beschreibung

Body mass index | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women or 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 (as defined by protocol)
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
positive for hepatitis b or hiv infection
Beschreibung

Hepatitis B positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C0019699
history of pre-existing renal disease
Beschreibung

Kidney Disease Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2347662
history of severe cardiac disease
Beschreibung

Heart Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
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 drug abuse within the last year; history of cannabinoid use is not excluded
Beschreibung

Drug abuse | Cannabinoids allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0006864
UMLS CUI [2,2]
C0683607
evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
Beschreibung

Alcohol abuse | Alcohol consumption U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0456683
medical condition that requires use of systemic corticosteroids
Beschreibung

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
Beschreibung

Warfarin Recent | Anticoagulants Recent | Warfarin Expected | Anticoagulants Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0043031
UMLS CUI [3,2]
C1517001
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C1517001
anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
Beschreibung

Therapeutic procedure Significant Anticipated | Patient need for Therapeutic procedure Significant | Pharmaceutical Preparations Excluded | Nutrients Excluded | Pharmaceutical Preparations Contraindicated Ritonavir | Pharmaceutical Preparations Contraindicated Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C3840775
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0678695
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C1444657
UMLS CUI [5,3]
C0292818
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1444657
UMLS CUI [6,3]
C2985296
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Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT01628094

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Genotype Duration
Item
chronic hepatitis c genotype 1 of >/= 6 months duration at screening
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
PEGINTERFERON Absent | Interferon Absent | DIRECT ACTING ANTIVIRALS Study Subject Participation Status Excluded
Item
part 1 and part 2: naïve to treatment with interferon (pegylated or non-pegylated). patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded
boolean
C0982327 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3653501 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Therapy Experience | Non-responder Interferon therapy
Item
part 2: treatment experienced patients having a previous null response to treatment with interferon containing regimen
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
Biopsy of liver | Evaluation | Fibroscan | Liver Cirrhosis Absent | Absence Liver Cirrhosis Incomplete | Absence Transition Liver Cirrhosis
Item
liver biopsy or non-invasive (e.g. fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis
boolean
C0193388 (UMLS CUI [1])
C1261322 (UMLS CUI [2])
C4522043 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0332197 (UMLS CUI [5,1])
C0023890 (UMLS CUI [5,2])
C0205257 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C2700061 (UMLS CUI [6,2])
C0023890 (UMLS CUI [6,3])
Body mass index | Body Weight
Item
body mass index (bmi) 18 to 35 kg/m2 inclusive and body weight >/= 45 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Gender Partner Pregnancy | Gender Partner Breast Feeding
Item
pregnant or lactating women or 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 (as defined by protocol)
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 positive | HIV Seropositivity
Item
positive for hepatitis b or hiv infection
boolean
C0856706 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Kidney Disease Pre-existing
Item
history of pre-existing renal disease
boolean
C0022658 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Heart Disease Severe
Item
history of severe cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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])
Drug abuse | Cannabinoids allowed
Item
history of drug abuse within the last year; history of cannabinoid use is not excluded
boolean
C0013146 (UMLS CUI [1])
C0006864 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Alcohol abuse | Alcohol consumption U/day
Item
evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day
boolean
C0085762 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE
Item
medical condition that requires use of systemic corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
Warfarin Recent | Anticoagulants Recent | Warfarin Expected | Anticoagulants Expected
Item
received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study
boolean
C0043031 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0003280 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0043031 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
C0003280 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Therapeutic procedure Significant Anticipated | Patient need for Therapeutic procedure Significant | Pharmaceutical Preparations Excluded | Nutrients Excluded | Pharmaceutical Preparations Contraindicated Ritonavir | Pharmaceutical Preparations Contraindicated Hormonal contraception
Item
anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)
boolean
C0087111 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0678695 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C1444657 (UMLS CUI [5,2])
C0292818 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C1444657 (UMLS CUI [6,2])
C2985296 (UMLS CUI [6,3])
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