ID

40914

Descripción

Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01371578

Link

https://clinicaltrials.gov/show/NCT01371578

Palabras clave

Versiones (1)
  1. 4/6/20 4/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01371578

Inglés

Eligibility Hepatitis C, Chronic NCT01371578

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, aged from 18 to 70 years old, inclusive
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
chronic hcv infection for at least 6 months prior to baseline
Descripción

Chronic Hepatitis C Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis.
Descripción

Liver Cirrhosis Absent Biopsy of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0193388
monoinfection with hcv genotype 1
Descripción

Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
hcv rna > 10^4 iu/ml at screening
Descripción

Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1272251
prior treatment and adherence (as defined by receiving at least 80% of the prescribed treatment) with one course of a pegylated interferon-alfa (pegasys or peg-intron) and rbv
Descripción

Course Pegasys | Course Pegintron | Course Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1176430
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C1527737
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
Descripción

Medical Records | peginterferon alfa-2a | peginterferon alfa-2b | Ribavirin | Antiviral Response

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025102
UMLS CUI [2]
C0391001
UMLS CUI [3]
C0796545
UMLS CUI [4]
C0035525
UMLS CUI [5]
C1155328
non-responder: subject did not achieve undetectable hcv rna levels during or at the end of a treatment period of at least 12 weeks duration. within nonresponders, subjects will be further defined as null or partial responders if they had < 2 log10 or ≥ 2 log10 reduction, respectively, in hcv rna during the first 12 weeks of treatment
Descripción

Therapy non-responder | Partial responder to therapy | Hepatitis C RNA Reduction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2]
C1740822
UMLS CUI [3,1]
C0855840
UMLS CUI [3,2]
C0392756
responder: subject achieved undetectable hcv rna during treatment. within responders, subjects will be further defined as relapsers if they had undetectable hcv rna at the end of at least 42 weeks of treatment but detectable hcv rna levels observed within 1 year of the end of treatment and breakthrough subjects if they achieved undetectable hcv rna levels during the treatment period but detectable hcv rna at the end of treatment.
Descripción

Therapy responder | Hepatitis C RNA Undetectable | Relapse | Hepatitis C RNA Detectable | Viral Breakthrough

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919876
UMLS CUI [2,1]
C0855840
UMLS CUI [2,2]
C3827727
UMLS CUI [3]
C0035020
UMLS CUI [4,1]
C0855840
UMLS CUI [4,2]
C3830527
UMLS CUI [5]
C4053869
no prior treatment with an oral hcv antiviral (exclusive of rbv).
Descripción

Antiviral Agents Oral Absent HCV | Exception Ribavirin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003451
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0220847
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0035525
body mass index (bmi) 18-36 kg/m2, inclusive.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
screening ecg without clinically significant abnormalities and with qtcf interval (qt corrected using fridericia's formula) ≤ 450 msec for males and ≤ 470 msec for females
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C1882513
UMLS CUI [3]
C0079399
creatinine clearance ≥ 50 ml/min.
Descripción

Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0373595
agree to use two forms of highly effective contraception for the duration of the study and for 6 months after the last dose of study medication. females of childbearing potential must have a negative pregnancy test at screening and baseline
Descripción

Contraceptive methods Quantity | Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

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

Exclusion Criteria

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

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

Tipo de datos

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
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023530
UMLS CUI [1,2]
C0443129
UMLS CUI [2,1]
C0027947
UMLS CUI [2,2]
C0443129
UMLS CUI [3,1]
C0002871
UMLS CUI [3,2]
C0443129
UMLS CUI [4,1]
C0040034
UMLS CUI [4,2]
C0443129
UMLS CUI [5,1]
C0040160
UMLS CUI [5,2]
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), or another hcv genotype, hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
Descripción

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

Tipo de datos

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]
C1148363
UMLS CUI [9]
C2239176
UMLS CUI [10]
C1707251
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0699893
UMLS CUI [12]
C0019045
UMLS CUI [13]
C0035309
UMLS CUI [14]
C4048329
current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. subjects on stable methadone are excluded, however stable buprenorphine maintenance treatment for at least 6 months is not exclusionary
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002667
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0376196
UMLS CUI [4]
C0026549
UMLS CUI [5]
C0011892
UMLS CUI [6]
C0085762
UMLS CUI [7,1]
C0025605
UMLS CUI [7,2]
C0205360
UMLS CUI [8,1]
C0006405
UMLS CUI [8,2]
C0205360
UMLS CUI [8,3]
C0683607
receiving any of the prohibited concomitant medications.
Descripción

Illicit medication use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281875
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Similar models

Eligibility Hepatitis C, Chronic NCT01371578

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, aged from 18 to 70 years old, inclusive
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length
Item
chronic hcv infection for at least 6 months prior to baseline
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Liver Cirrhosis Absent Biopsy of liver
Item
subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis.
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Hepatitis C Genotype
Item
monoinfection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
hcv rna > 10^4 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Course Pegasys | Course Pegintron | Course Ribavirin
Item
prior treatment and adherence (as defined by receiving at least 80% of the prescribed treatment) with one course of a pegylated interferon-alfa (pegasys or peg-intron) and rbv
boolean
C0750729 (UMLS CUI [1,1])
C1176430 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C1527737 (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
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
boolean
C0025102 (UMLS CUI [1])
C0391001 (UMLS CUI [2])
C0796545 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C1155328 (UMLS CUI [5])
Therapy non-responder | Partial responder to therapy | Hepatitis C RNA Reduction
Item
non-responder: subject did not achieve undetectable hcv rna levels during or at the end of a treatment period of at least 12 weeks duration. within nonresponders, subjects will be further defined as null or partial responders if they had < 2 log10 or ≥ 2 log10 reduction, respectively, in hcv rna during the first 12 weeks of treatment
boolean
C0919875 (UMLS CUI [1])
C1740822 (UMLS CUI [2])
C0855840 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
Therapy responder | Hepatitis C RNA Undetectable | Relapse | Hepatitis C RNA Detectable | Viral Breakthrough
Item
responder: subject achieved undetectable hcv rna during treatment. within responders, subjects will be further defined as relapsers if they had undetectable hcv rna at the end of at least 42 weeks of treatment but detectable hcv rna levels observed within 1 year of the end of treatment and breakthrough subjects if they achieved undetectable hcv rna levels during the treatment period but detectable hcv rna at the end of treatment.
boolean
C0919876 (UMLS CUI [1])
C0855840 (UMLS CUI [2,1])
C3827727 (UMLS CUI [2,2])
C0035020 (UMLS CUI [3])
C0855840 (UMLS CUI [4,1])
C3830527 (UMLS CUI [4,2])
C4053869 (UMLS CUI [5])
Antiviral Agents Oral Absent HCV | Exception Ribavirin
Item
no prior treatment with an oral hcv antiviral (exclusive of rbv).
boolean
C0003451 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0220847 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi) 18-36 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) ≤ 450 msec for males and ≤ 470 msec for females
boolean
C0522054 (UMLS CUI [1])
C0489625 (UMLS CUI [2,1])
C1882513 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance ≥ 50 ml/min.
boolean
C0373595 (UMLS CUI [1])
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 6 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
discontinued 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])
Leukopenia Above threshold | Neutropenia Above threshold | Anemia Above threshold | Thrombocytopenia Above threshold | Thyroid stimulating hormone Above threshold
Item
exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh)
boolean
C0023530 (UMLS CUI [1,1])
C0443129 (UMLS CUI [1,2])
C0027947 (UMLS CUI [2,1])
C0443129 (UMLS CUI [2,2])
C0002871 (UMLS CUI [3,1])
C0443129 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4,1])
C0443129 (UMLS CUI [4,2])
C0040160 (UMLS CUI [5,1])
C0443129 (UMLS CUI [5,2])
Autoimmune Disease | Decompensated liver disease | Poorly controlled diabetes mellitus | Mental disorders | Severe chronic obstructive pulmonary disease | HIV | Hepatitis B Virus | Hepatitis C virus genotype | Liver carcinoma | Cancer Other | Exception Skin carcinoma | Hemoglobinopathy | Retinal Diseases | 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), or another hcv genotype, hepatocellular carcinoma or other malignancy (with exception of certain 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])
C1148363 (UMLS CUI [8])
C2239176 (UMLS CUI [9])
C1707251 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0699893 (UMLS CUI [11,2])
C0019045 (UMLS CUI [12])
C0035309 (UMLS CUI [13])
C4048329 (UMLS CUI [14])
Amphetamines | Cocaine | Opiates | Morphine | Heroin | Alcohol abuse | Methadone Stable | Buprenorphine Stable allowed
Item
current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. subjects on stable methadone are excluded, however stable buprenorphine maintenance treatment for at least 6 months is not exclusionary
boolean
C0002667 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0376196 (UMLS CUI [3])
C0026549 (UMLS CUI [4])
C0011892 (UMLS CUI [5])
C0085762 (UMLS CUI [6])
C0025605 (UMLS CUI [7,1])
C0205360 (UMLS CUI [7,2])
C0006405 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Illicit medication use
Item
receiving any of the prohibited concomitant medications.
boolean
C0281875 (UMLS CUI [1])
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