ID

39582

Beschreibung

Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00919633

Link

https://clinicaltrials.gov/show/NCT00919633

Stichworte

Versionen (1)
  1. 31.01.20 31.01.20 -
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See clinicaltrials.gov

Hochgeladen am

31. Januar 2020

DOI

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Eligibility Hepatitis C NCT00919633

Englisch

Eligibility Hepatitis C NCT00919633

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed patient consent form
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
genotype 1 chronic hcv with detectable hcv rna
Beschreibung

Chronic Hepatitis C Genotype | Hepatitis C virus RNA Detectable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
no previous treatment for hcv infection
Beschreibung

Prior Therapy Absent Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019196
hepatitis b and human immunodeficiency virus negative at screening visit
Beschreibung

Hepatitis B test negative | HIV negative

Datentyp

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C0481430
able and willing to follow contraception requirements
Beschreibung

Contraceptive methods Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
screening laboratory values, test, and physical exam within acceptable ranges
Beschreibung

Laboratory Results Acceptable | Test Result Acceptable | Physical Examination Acceptable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0456984
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C1879533
weight between 40 kg and 125 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
proficiency in the use of the external pump infusion system
Beschreibung

Use of External Infusion Pump

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0021437
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or planned enrollment in another investigational device or drug study
Beschreibung

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
anticipated inability to complete all clinic visits and comply with study procedures
Beschreibung

Clinic Visits Complete Unable | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
history of, or any current medical condition, which could impact the safety of the subject during the study
Beschreibung

Medical condition Impact Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C1113679
autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than hcv
Beschreibung

Hepatitis, Autoimmune | Liver carcinoma Suspected | Decompensated liver disease | Liver disease Except Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C4075847
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0019196
alcoholism or substance abuse with <6 documented months of sobriety
Beschreibung

Alcoholic Intoxication, Chronic | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0038586
known allergy or sensitivity to interferons or ribavirin
Beschreibung

Interferons allergy | Ribavirin allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571288
UMLS CUI [2]
C0571293
any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
Beschreibung

Condition Study Subject Participation Status Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2732579
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Ähnliche Modelle

Eligibility Hepatitis C NCT00919633

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed patient consent form
boolean
C0021430 (UMLS CUI [1])
Chronic Hepatitis C Genotype | Hepatitis C virus RNA Detectable
Item
genotype 1 chronic hcv with detectable hcv rna
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
Prior Therapy Absent Hepatitis C
Item
no previous treatment for hcv infection
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis B test negative | HIV negative
Item
hepatitis b and human immunodeficiency virus negative at screening visit
boolean
C1611173 (UMLS CUI [1])
C0481430 (UMLS CUI [2])
Contraceptive methods Willing
Item
able and willing to follow contraception requirements
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Laboratory Results Acceptable | Test Result Acceptable | Physical Examination Acceptable
Item
screening laboratory values, test, and physical exam within acceptable ranges
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Body Weight
Item
weight between 40 kg and 125 kg
boolean
C0005910 (UMLS CUI [1])
Use of External Infusion Pump
Item
proficiency in the use of the external pump infusion system
boolean
C1524063 (UMLS CUI [1,1])
C0021437 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
current or planned enrollment in another investigational device or drug study
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Clinic Visits Complete Unable | Protocol Compliance Unable
Item
anticipated inability to complete all clinic visits and comply with study procedures
boolean
C0008952 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical condition Impact Patient safety
Item
history of, or any current medical condition, which could impact the safety of the subject during the study
boolean
C3843040 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
Hepatitis, Autoimmune | Liver carcinoma Suspected | Decompensated liver disease | Liver disease Except Hepatitis C
Item
autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than hcv
boolean
C0241910 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C4075847 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0019196 (UMLS CUI [4,3])
Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
alcoholism or substance abuse with <6 documented months of sobriety
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Interferons allergy | Ribavirin allergy
Item
known allergy or sensitivity to interferons or ribavirin
boolean
C0571288 (UMLS CUI [1])
C0571293 (UMLS CUI [2])
Condition Study Subject Participation Status Inappropriate | Condition Interferes with Study Subject Participation Status | Condition Interferes with Completion of clinical trial
Item
any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
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