ID

39640

Descripción

Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01431898

Link

https://clinicaltrials.gov/show/NCT01431898

Palabras clave

Versiones (1)
  1. 7/2/20 7/2/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de febrero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01431898

Inglés

Eligibility Hepatitis C NCT01431898

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects 18-65 years of old, inclusive
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
documented chronic hcv infection to be of at least 6 months duration and plasma hcv rna ≥ 5 log10 iu/ml at screening.
Descripción

Chronic Hepatitis C Duration | Plasma Hepatitis C virus RNA assay

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C1272251
hcv treatment naïve or peg-ifn, ifn, and/or rbv experienced (treatment must have ceased at least 3 months prior to screening). treatment experienced subjects should not exceed 40% of the subjects enrolled in each cohort
Descripción

Hepatitis C virus Therapy naive | PEGINTERFERON | Interferon | Ribavirin | Therapeutic procedure To be stopped

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0220847
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0982327
UMLS CUI [3]
C3652465
UMLS CUI [4]
C0035525
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1272691
mono-infection with hcv genotype 1a for cohorts 1, 2, 3, 4, and 5 and mono-infection with hcv genotype 1b for cohort 6 and 7.
Descripción

Hepatitis C Genotype | Cohort Number

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0599755
UMLS CUI [2,2]
C0237753
estimated creatinine clearance ≥ 70 ml/min,
Descripción

Creatinine clearance measurement Estimated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0750572
qtcf interval ≤ 450 msec for males and ≤ 470 msec for females, qrs duration < 120 msec, pr interval < 220 msec,
Descripción

QTC interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1882513
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0429025
UMLS CUI [4]
C0429024
body mass index (bmi) of 19.0 to 34.0 kg/m^2, inclusive.
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
urine drug screen positive for illicit/illegal drugs
Descripción

Urine drug screen positive Illicit Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0086190
alt and ast levels > 5 times the upper limit of the normal range (uln)
Descripción

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
direct bilirubin > uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 90,000/mm^3, prothrombin time ≥ 1.5 × uln and albumin < 3.5 g/dl) are not eligible for study participation.
Descripción

Direct bilirubin increased | Hepatic decompensation | Platelet Count measurement | Prothrombin time increased | Albumin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0740434
UMLS CUI [2]
C1394798
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0151872
UMLS CUI [5]
C0201838
subjects with an absolute neutrophil count (anc) < 1,000 cells/mm^3 (< 750 cells/mm^3 for black or african-american subjects), hemoglobin (hb) < 11 g/dl,
Descripción

Absolute neutrophil count | African American | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0085756
UMLS CUI [3]
C0518015
coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype other than genotype 1a/b are not eligible for study participation.
Descripción

HBV coinfection | Human immunodeficiency virus (HIV) coinfection | HCV coinfection Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
UMLS CUI [3,1]
C1698259
UMLS CUI [3,2]
C1533728
evidence of hepatocellular carcinoma (e.g., a-fetoprotein > 50 ng/ml or as indicated by recent ultrasound or other standard of care measure)
Descripción

Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonography | Standard of Care

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0201539
UMLS CUI [3]
C0041618
UMLS CUI [4]
C2936643
history of significant cardiac disease. the following ecg abnormalities at screening are exclusionary: qtcf (qt corrected using fridericia's formula=qt/rr^0.333) > 450 msec for males and > 470 for females; qrs > 120 msec (left or right hemiblock is not exclusionary); pr interval > 220 msec; bradycardia (< 45 beats per minute); second or third degree heart block.
Descripción

Heart Disease | Electrocardiogram abnormal | Prolonged QTc interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration | Bradycardia beats per minute | Second degree atrioventricular block | Complete atrioventricular block

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0522055
UMLS CUI [3,1]
C1560305
UMLS CUI [3,2]
C1882513
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0429025
UMLS CUI [6]
C0429024
UMLS CUI [7,1]
C0428977
UMLS CUI [7,2]
C0439385
UMLS CUI [8]
C0264906
UMLS CUI [9]
C0151517
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Descripción

Illness Clinical Significance Interferes with Therapeutic procedure | Illness Clinical Significance Interferes with Assessment | Illness Clinical Significance Interferes with Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C1516048
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Descripción

Gastrointestinal Disease Interferes with Absorption Investigational New Drug | Gastrointestinal Disease Interferes with Anatomy gastrointestinal | Gastrointestinal Disease Interferes with Gastrointestinal Motility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0700276
UMLS CUI [2,4]
C0521362
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0017184
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Similar models

Eligibility Hepatitis C NCT01431898

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult subjects 18-65 years of old, inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Duration | Plasma Hepatitis C virus RNA assay
Item
documented chronic hcv infection to be of at least 6 months duration and plasma hcv rna ≥ 5 log10 iu/ml at screening.
boolean
C0524910 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0032105 (UMLS CUI [2,1])
C1272251 (UMLS CUI [2,2])
Hepatitis C virus Therapy naive | PEGINTERFERON | Interferon | Ribavirin | Therapeutic procedure To be stopped
Item
hcv treatment naïve or peg-ifn, ifn, and/or rbv experienced (treatment must have ceased at least 3 months prior to screening). treatment experienced subjects should not exceed 40% of the subjects enrolled in each cohort
boolean
C0220847 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0982327 (UMLS CUI [2])
C3652465 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Hepatitis C Genotype | Cohort Number
Item
mono-infection with hcv genotype 1a for cohorts 1, 2, 3, 4, and 5 and mono-infection with hcv genotype 1b for cohort 6 and 7.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0599755 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Creatinine clearance measurement Estimated
Item
estimated creatinine clearance ≥ 70 ml/min,
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
QTC interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration
Item
qtcf interval ≤ 450 msec for males and ≤ 470 msec for females, qrs duration < 120 msec, pr interval < 220 msec,
boolean
C0489625 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0429024 (UMLS CUI [4])
Body mass index
Item
body mass index (bmi) of 19.0 to 34.0 kg/m^2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Urine drug screen positive Illicit Drugs
Item
urine drug screen positive for illicit/illegal drugs
boolean
C0743300 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt and ast levels > 5 times the upper limit of the normal range (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Direct bilirubin increased | Hepatic decompensation | Platelet Count measurement | Prothrombin time increased | Albumin measurement
Item
direct bilirubin > uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 90,000/mm^3, prothrombin time ≥ 1.5 × uln and albumin < 3.5 g/dl) are not eligible for study participation.
boolean
C0740434 (UMLS CUI [1])
C1394798 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0151872 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
Absolute neutrophil count | African American | Hemoglobin measurement
Item
subjects with an absolute neutrophil count (anc) < 1,000 cells/mm^3 (< 750 cells/mm^3 for black or african-american subjects), hemoglobin (hb) < 11 g/dl,
boolean
C0948762 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
HBV coinfection | Human immunodeficiency virus (HIV) coinfection | HCV coinfection Genotype
Item
coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype other than genotype 1a/b are not eligible for study participation.
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3,1])
C1533728 (UMLS CUI [3,2])
Liver carcinoma | Alpha one fetoprotein measurement | Ultrasonography | Standard of Care
Item
evidence of hepatocellular carcinoma (e.g., a-fetoprotein > 50 ng/ml or as indicated by recent ultrasound or other standard of care measure)
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0041618 (UMLS CUI [3])
C2936643 (UMLS CUI [4])
Heart Disease | Electrocardiogram abnormal | Prolonged QTc interval QTcF - Fridericia's Correction Formula | Gender | QRS duration | PR interval duration | Bradycardia beats per minute | Second degree atrioventricular block | Complete atrioventricular block
Item
history of significant cardiac disease. the following ecg abnormalities at screening are exclusionary: qtcf (qt corrected using fridericia's formula=qt/rr^0.333) > 450 msec for males and > 470 for females; qrs > 120 msec (left or right hemiblock is not exclusionary); pr interval > 220 msec; bradycardia (< 45 beats per minute); second or third degree heart block.
boolean
C0018799 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C1560305 (UMLS CUI [3,1])
C1882513 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C0429025 (UMLS CUI [5])
C0429024 (UMLS CUI [6])
C0428977 (UMLS CUI [7,1])
C0439385 (UMLS CUI [7,2])
C0264906 (UMLS CUI [8])
C0151517 (UMLS CUI [9])
Illness Clinical Significance Interferes with Therapeutic procedure | Illness Clinical Significance Interferes with Assessment | Illness Clinical Significance Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
Gastrointestinal Disease Interferes with Absorption Investigational New Drug | Gastrointestinal Disease Interferes with Anatomy gastrointestinal | Gastrointestinal Disease Interferes with Gastrointestinal Motility
Item
history of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0700276 (UMLS CUI [2,3])
C0521362 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])
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