ID

40915

Beskrivning

GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01435226

Länk

https://clinicaltrials.gov/show/NCT01435226

Nyckelord

Versioner (1)
  1. 2020-06-04 2020-06-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01435226

Engelsk

Eligibility Hepatitis C, Chronic NCT01435226

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years with chronic hcv infection
Beskrivning

Age | Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0524910
liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
Beskrivning

Liver Cirrhosis Absent Biopsy of liver | Noninvasive procedure allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0814177
UMLS CUI [2,2]
C0683607
monoinfection with hcv genotype (gt) 1a or 1b
Beskrivning

Hepatitis C Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
hcv rna ≥ 104 iu/ml at screening
Beskrivning

Hepatitis C virus RNA assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1272251
prior treatment and adherence with one course of pegylated interferon alfa and rbv
Beskrivning

Course Peginterferon alfa-2a | Course Peginterferon alfa-2b | Course Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0391001
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C0796545
UMLS CUI [3,1]
C0750729
UMLS CUI [3,2]
C0035525
the subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and rbv (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
Beskrivning

Medical Records | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Antiviral Response | Therapy non-responder | Partial responder to therapy | Viral Breakthrough | Relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0025102
UMLS CUI [2]
C0391001
UMLS CUI [3]
C0796545
UMLS CUI [4]
C0035525
UMLS CUI [5]
C1155328
UMLS CUI [6]
C0919875
UMLS CUI [7]
C1740822
UMLS CUI [8]
C4053869
UMLS CUI [9]
C0035020
body mass index (bmi) 18-40 kg/m2 inclusive
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
screening ecg without clinically significant abnormalities and with qtcf interval (qt corrected using fridericia's formula)
Beskrivning

ECG normal | QTc interval QTcF - Fridericia's Correction Formula | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C1882513
UMLS CUI [3]
C0079399
≤ 450 msec for males and ≤ 470 msec for females.
Beskrivning

ID.9

Datatyp

boolean

agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have a negative pregnancy test at screening and baseline.
Beskrivning

Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
discontinuation of prior treatment with pegylated interferon alfa and rbv due to an adverse event, toxicity reasons or were lost to follow-up
Beskrivning

Peginterferon alfa-2a Discontinued | Peginterferon alfa-2b Discontinued | Ribavirin Discontinued | Cause Adverse event | Cause Toxicity | Patient unavailable Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0391001
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0796545
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0035525
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0877248
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0600688
UMLS CUI [6,1]
C1301818
UMLS CUI [6,2]
C3274571
history of significant cardiac disease
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
exceed criteria delineated in section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (tsh).
Beskrivning

Laboratory Results Above threshold | Leukopenia Above threshold | Neutropenia Above threshold | Anemia Above threshold | Thrombocytopenia Above threshold | Thyroid stimulating hormone Above threshold

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0443129
UMLS CUI [2,1]
C0023530
UMLS CUI [2,2]
C0443129
UMLS CUI [3,1]
C0027947
UMLS CUI [3,2]
C0443129
UMLS CUI [4,1]
C0002871
UMLS CUI [4,2]
C0443129
UMLS CUI [5,1]
C0040034
UMLS CUI [5,2]
C0443129
UMLS CUI [6,1]
C0040160
UMLS CUI [6,2]
C0443129
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
Beskrivning

Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Cancer Other | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Disease | Immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C4075847
UMLS CUI [3]
C0554876
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0730607
UMLS CUI [6]
C0019682
UMLS CUI [7]
C0019169
UMLS CUI [8]
C2239176
UMLS CUI [9]
C1707251
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0699893
UMLS CUI [10,3]
C1514893
UMLS CUI [11]
C0019045
UMLS CUI [12]
C0035309
UMLS CUI [13]
C4048329
current abuse of amphetamines, cocaine, opiates, or alcohol. methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
Beskrivning

Amphetamines | Cocaine | Opiates | Alcohol abuse | Methadone | Buprenorphine Stable allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0002667
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0376196
UMLS CUI [4]
C0085762
UMLS CUI [5]
C0025605
UMLS CUI [6,1]
C0006405
UMLS CUI [6,2]
C0205360
UMLS CUI [6,3]
C0683607
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Similar models

Eligibility Hepatitis C, Chronic NCT01435226

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hepatitis C, Chronic
Item
age ≥18 years with chronic hcv infection
boolean
C0001779 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
Liver Cirrhosis Absent Biopsy of liver | Noninvasive procedure allowed
Item
liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0814177 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Hepatitis C Genotype
Item
monoinfection with hcv genotype (gt) 1a or 1b
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna ≥ 104 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Course Peginterferon alfa-2a | Course Peginterferon alfa-2b | Course Ribavirin
Item
prior treatment and adherence with one course of pegylated interferon alfa and rbv
boolean
C0750729 (UMLS CUI [1,1])
C0391001 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0796545 (UMLS CUI [2,2])
C0750729 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
Medical Records | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Antiviral Response | Therapy non-responder | Partial responder to therapy | Viral Breakthrough | Relapse
Item
the subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and rbv (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
boolean
C0025102 (UMLS CUI [1])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C1155328 (UMLS CUI [5])
C0919875 (UMLS CUI [6])
C1740822 (UMLS CUI [7])
C4053869 (UMLS CUI [8])
C0035020 (UMLS CUI [9])
Body mass index
Item
body mass index (bmi) 18-40 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
ECG normal | QTc interval QTcF - Fridericia's Correction Formula | Gender
Item
screening ecg without clinically significant abnormalities and with qtcf interval (qt corrected using fridericia's formula)
boolean
C0522054 (UMLS CUI [1])
C0489625 (UMLS CUI [2,1])
C1882513 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
ID.9
Item
≤ 450 msec for males and ≤ 470 msec for females.
boolean
Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative
Item
agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have a negative pregnancy test at screening and baseline.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Peginterferon alfa-2a Discontinued | Peginterferon alfa-2b Discontinued | Ribavirin Discontinued | Cause Adverse event | Cause Toxicity | Patient unavailable Follow-up
Item
discontinuation of prior treatment with pegylated interferon alfa and rbv due to an adverse event, toxicity reasons or were lost to follow-up
boolean
C0391001 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C1301818 (UMLS CUI [6,1])
C3274571 (UMLS CUI [6,2])
Heart Disease
Item
history of significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Laboratory Results Above threshold | Leukopenia Above threshold | Neutropenia Above threshold | Anemia Above threshold | Thrombocytopenia Above threshold | Thyroid stimulating hormone Above threshold
Item
exceed criteria delineated in section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (tsh).
boolean
C1254595 (UMLS CUI [1,1])
C0443129 (UMLS CUI [1,2])
C0023530 (UMLS CUI [2,1])
C0443129 (UMLS CUI [2,2])
C0027947 (UMLS CUI [3,1])
C0443129 (UMLS CUI [3,2])
C0002871 (UMLS CUI [4,1])
C0443129 (UMLS CUI [4,2])
C0040034 (UMLS CUI [5,1])
C0443129 (UMLS CUI [5,2])
C0040160 (UMLS CUI [6,1])
C0443129 (UMLS CUI [6,2])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Liver carcinoma | Cancer Other | Exception Skin carcinoma resolved | Hemoglobinopathy | Retinal Disease | Immunosuppression
Item
diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
boolean
C0004364 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C0554876 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0730607 (UMLS CUI [5])
C0019682 (UMLS CUI [6])
C0019169 (UMLS CUI [7])
C2239176 (UMLS CUI [8])
C1707251 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0699893 (UMLS CUI [10,2])
C1514893 (UMLS CUI [10,3])
C0019045 (UMLS CUI [11])
C0035309 (UMLS CUI [12])
C4048329 (UMLS CUI [13])
Amphetamines | Cocaine | Opiates | Alcohol abuse | Methadone | Buprenorphine Stable allowed
Item
current abuse of amphetamines, cocaine, opiates, or alcohol. methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0085762 (UMLS CUI [4])
C0025605 (UMLS CUI [5])
C0006405 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
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