ID

39706

Beskrivning

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01316237

Länk

https://clinicaltrials.gov/show/NCT01316237

Nyckelord

Versioner (1)
  1. 2020-02-11 2020-02-11 -
Rättsinnehavare

See clinicaltrials.gov

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11 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01316237

Engelsk

Eligibility Hepatitis C, Chronic NCT01316237

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult subjects (18-60 years of age or up to 64 years of age with approval)
Beskrivning

Adult | Age

Datatyp

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.
Beskrivning

Chronic Hepatitis C Duration | Hepatitis C virus RNA assay Plasma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C1272251
UMLS CUI [2,2]
C0032105
hcv treatment naïve
Beskrivning

Therapy naive Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
estimated creatinine clearance ≥ 80 ml/min,
Beskrivning

Creatinine clearance measurement Estimated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0750572
qtcf interval ≤ 450 msec, qrs duration < 100 msec, pr interval < 220 msec,
Beskrivning

QTc interval Fridericia's Correction Formula | QRS duration | PR interval duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1882513
UMLS CUI [2]
C0429025
UMLS CUI [3]
C0429024
body mass index (bmi) of 19.0 to 34.0 kg/m2, inclusive.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
eligible subjects must also be hcv treatment-naïve.
Beskrivning

Therapy naive Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/ml or by any other standard of care measure)
Beskrivning

Liver Cirrhosis | Alcohol intake above recommended sensible limits | Liver carcinoma | Alpha one fetoprotein measurement | Standard of Care Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0560219
UMLS CUI [3]
C2239176
UMLS CUI [4]
C0201539
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C0242485
urine drug screen positive for illicit/illegal drugs
Beskrivning

Urine drug screen positive Illicit Drugs

Datatyp

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)
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
direct bilirubin > uln, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × uln and albumin < 3.5 g/dl) are not eligible for study participation.
Beskrivning

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

Datatyp

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/mm3 (< 750 cells/mm3 for black or african-american subjects), hemoglobin (hb) < 11 g/dl,
Beskrivning

Absolute neutrophil count | African American | Hemoglobin measurement

Datatyp

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 type 1 for cohorts 1-5 and type 2 or 3 for cohort 6) are not eligible for study participation.
Beskrivning

HBV coinfection | Human immunodeficiency virus (HIV) coinfection | HCV coinfection | Exception Hepatitis C virus genotype

Datatyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
UMLS CUI [3]
C1698259
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1533728
evidence of hepatocellular carcinoma
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
any sign of decompensated liver disease, including prothrombin time ≥ 1.5 x uln, platelets < 100,000/mm3 or albumin < 3.5 g/dl at screening or current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
Beskrivning

Sign Decompensated liver disease | Prothrombin time increased | Platelet Count measurement | Albumin measurement | Hepatic decompensation | Ascites | Icterus | Encephalopathy | Bleeding varices

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C4075847
UMLS CUI [2]
C0151872
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201838
UMLS CUI [5]
C1394798
UMLS CUI [6]
C0003962
UMLS CUI [7]
C0022346
UMLS CUI [8]
C0085584
UMLS CUI [9]
C0333106
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Beskrivning

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

Datatyp

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]
C0012634
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0087111
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C1516048
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C1516048
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C0525058
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
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
Beskrivning

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

Datatyp

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, Chronic NCT01316237

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult subjects (18-60 years of age or up to 64 years of age with approval)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C Duration | Hepatitis C virus RNA assay Plasma
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])
C1272251 (UMLS CUI [2,1])
C0032105 (UMLS CUI [2,2])
Therapy naive Hepatitis C
Item
hcv treatment naïve
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Creatinine clearance measurement Estimated
Item
estimated creatinine clearance ≥ 80 ml/min,
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
QTc interval Fridericia's Correction Formula | QRS duration | PR interval duration
Item
qtcf interval ≤ 450 msec, qrs duration < 100 msec, pr interval < 220 msec,
boolean
C0489625 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
C0429025 (UMLS CUI [2])
C0429024 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) of 19.0 to 34.0 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Therapy naive Hepatitis C
Item
eligible subjects must also be hcv treatment-naïve.
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Liver Cirrhosis | Alcohol intake above recommended sensible limits | Liver carcinoma | Alpha one fetoprotein measurement | Standard of Care Measurement
Item
subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/ml or by any other standard of care measure)
boolean
C0023890 (UMLS CUI [1])
C0560219 (UMLS CUI [2])
C2239176 (UMLS CUI [3])
C0201539 (UMLS CUI [4])
C2936643 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
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 < 100,000/mm3, 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/mm3 (< 750 cells/mm3 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 | Exception Hepatitis C virus genotype
Item
coinfected with hepatitis b virus (hbv), human immunodeficiency virus (hiv), or another hcv genotype (other than type 1 for cohorts 1-5 and type 2 or 3 for cohort 6) are not eligible for study participation.
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
C1698259 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1533728 (UMLS CUI [4,2])
Liver carcinoma
Item
evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Sign Decompensated liver disease | Prothrombin time increased | Platelet Count measurement | Albumin measurement | Hepatic decompensation | Ascites | Icterus | Encephalopathy | Bleeding varices
Item
any sign of decompensated liver disease, including prothrombin time ≥ 1.5 x uln, platelets < 100,000/mm3 or albumin < 3.5 g/dl at screening or current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
boolean
C0311392 (UMLS CUI [1,1])
C4075847 (UMLS CUI [1,2])
C0151872 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C1394798 (UMLS CUI [5])
C0003962 (UMLS CUI [6])
C0022346 (UMLS CUI [7])
C0085584 (UMLS CUI [8])
C0333106 (UMLS CUI [9])
Illness Clinical Significance Interferes with Therapeutic procedure | Disease Major Interferes with Therapeutic procedure | Illness Clinical Significance Interferes with Assessment | Disease Major Interferes with Assessment | Illness Clinical Significance Interferes with Protocol Compliance | Disease Major 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])
C0012634 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1516048 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1516048 (UMLS CUI [4,4])
C0221423 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
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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