ID

36061

Description

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02421211

Link

https://clinicaltrials.gov/show/NCT02421211

Keywords

Versions (1)
  1. 4/12/19 4/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02421211

English

Eligibility Hepatitis C, Chronic NCT02421211

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with body mass index (weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter kg/m^2, extremes included
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
participants must be treatment-naive (that is, have not received prior treatment with any approved or investigational drug)
Description

Therapy naive | Pharmacotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
participants with hcv ribonucleic acid (rna) plasma levels greater than (>) 10,000 international unit per milliliter (iu/ml) and lower than 6,000,000 international unit per milliliter (iu/ml) at screening
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
participants with absence of cirrhosis confirmed by fibrotest/fibrosure score less or equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal to 2 or a fibroscan less or equal to 14.6 kilopascale (kpa), performed within 6 months prior or during the screening period
Description

Liver Cirrhosis Absent | FibroTest Score Measurement | AST to platelet ratio index | Fibroscan

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C3642160
UMLS CUI [3]
C4483916
UMLS CUI [4]
C4522043
participants with documented chronic hcv infection: diagnosis of hcv infection >6 months prior to screening, either by detectable hcv rna, an hcv positive antibody test or presence of histological changes consistent with chronic hepatitis in a liver biopsy
Description

Chronic Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C antibody positive | Change Histological Consistent with Chronic Hepatitis | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C3830527
UMLS CUI [3]
C0281863
UMLS CUI [4,1]
C0392747
UMLS CUI [4,2]
C0205462
UMLS CUI [4,3]
C0332290
UMLS CUI [4,4]
C0019189
UMLS CUI [5]
C0193388
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has infection/co-infection with hcv of a genotype other than genotype 1, human immunodeficiency virus (hiv) type 1 or 2
Description

Hepatitis C Genotype | HCV coinfection Genotype | Exception Hepatitis C virus genotype Specified | HIV Infection HIV-1 | HIV Infection HIV-2 | Coinfection HIV-1 | Coinfection HIV-2

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C1698259
UMLS CUI [2,2]
C1533728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1148363
UMLS CUI [3,3]
C0205369
UMLS CUI [4,1]
C0019693
UMLS CUI [4,2]
C0019704
UMLS CUI [5,1]
C0019693
UMLS CUI [5,2]
C0019707
UMLS CUI [6,1]
C0275524
UMLS CUI [6,2]
C0019704
UMLS CUI [7,1]
C0275524
UMLS CUI [7,2]
C0019707
participant has any evidence of liver disease of non-hcv etiology. this includes, but is not limited to acute hepatitis a, active hepatitis b, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hc liver disease considered clinically significant by the investigator
Description

Liver diseases | Etiology Absent Hepatitis C virus | Hepatitis A | Drug-Induced Liver Disease | Alcoholic Liver Diseases | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0220847
UMLS CUI [3]
C0019159
UMLS CUI [4]
C0860207
UMLS CUI [5]
C0023896
UMLS CUI [6]
C0241910
UMLS CUI [7]
C0018995
UMLS CUI [8]
C0019202
UMLS CUI [9]
C0221757
UMLS CUI [10]
C3241937
UMLS CUI [11]
C0008312
participant with significant co-morbidities, conditions or clinical significant findings during screening assessments that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
Description

Comorbidity compromises Patient safety | Condition compromises Patient safety | Finding compromises Patient safety | Comorbidity Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Finding Interferes with Study Subject Participation Status | Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Finding Interferes with Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0243095
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C0243095
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2732579
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2732579
UMLS CUI [9,1]
C0243095
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2732579
participant received an organ transplant (other than cornea or hair transplant or skin graft)
Description

Organ Transplantation | Exception Keratoplasty | Exception Hair transplant procedure | Exception Skin Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0010042
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0191626
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0037297
participants have key protocol defined laboratory abnormalities
Description

Laboratory test result abnormal Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hepatitis C, Chronic NCT02421211

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
participants with body mass index (weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter kg/m^2, extremes included
boolean
C1305855 (UMLS CUI [1])
Therapy naive | Pharmacotherapy Absent
Item
participants must be treatment-naive (that is, have not received prior treatment with any approved or investigational drug)
boolean
C0919936 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis C virus RNA assay
Item
participants with hcv ribonucleic acid (rna) plasma levels greater than (>) 10,000 international unit per milliliter (iu/ml) and lower than 6,000,000 international unit per milliliter (iu/ml) at screening
boolean
C1272251 (UMLS CUI [1])
Liver Cirrhosis Absent | FibroTest Score Measurement | AST to platelet ratio index | Fibroscan
Item
participants with absence of cirrhosis confirmed by fibrotest/fibrosure score less or equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal to 2 or a fibroscan less or equal to 14.6 kilopascale (kpa), performed within 6 months prior or during the screening period
boolean
C0023890 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3642160 (UMLS CUI [2])
C4483916 (UMLS CUI [3])
C4522043 (UMLS CUI [4])
Chronic Hepatitis C Disease length | Hepatitis C virus RNA Detectable | Hepatitis C antibody positive | Change Histological Consistent with Chronic Hepatitis | Biopsy of liver
Item
participants with documented chronic hcv infection: diagnosis of hcv infection >6 months prior to screening, either by detectable hcv rna, an hcv positive antibody test or presence of histological changes consistent with chronic hepatitis in a liver biopsy
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0281863 (UMLS CUI [3])
C0392747 (UMLS CUI [4,1])
C0205462 (UMLS CUI [4,2])
C0332290 (UMLS CUI [4,3])
C0019189 (UMLS CUI [4,4])
C0193388 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype | HCV coinfection Genotype | Exception Hepatitis C virus genotype Specified | HIV Infection HIV-1 | HIV Infection HIV-2 | Coinfection HIV-1 | Coinfection HIV-2
Item
participant has infection/co-infection with hcv of a genotype other than genotype 1, human immunodeficiency virus (hiv) type 1 or 2
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C0019693 (UMLS CUI [4,1])
C0019704 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5,1])
C0019707 (UMLS CUI [5,2])
C0275524 (UMLS CUI [6,1])
C0019704 (UMLS CUI [6,2])
C0275524 (UMLS CUI [7,1])
C0019707 (UMLS CUI [7,2])
Liver diseases | Etiology Absent Hepatitis C virus | Hepatitis A | Drug-Induced Liver Disease | Alcoholic Liver Diseases | Hepatitis, Autoimmune | Hemochromatosis | Hepatolenticular Degeneration | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis | Primary biliary cirrhosis
Item
participant has any evidence of liver disease of non-hcv etiology. this includes, but is not limited to acute hepatitis a, active hepatitis b, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-hc liver disease considered clinically significant by the investigator
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
C0019159 (UMLS CUI [3])
C0860207 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0241910 (UMLS CUI [6])
C0018995 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
C3241937 (UMLS CUI [10])
C0008312 (UMLS CUI [11])
Comorbidity compromises Patient safety | Condition compromises Patient safety | Finding compromises Patient safety | Comorbidity Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Finding Interferes with Study Subject Participation Status | Comorbidity Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial | Finding Interferes with Completion of clinical trial
Item
participant with significant co-morbidities, conditions or clinical significant findings during screening assessments that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0243095 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0243095 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0009488 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
C0243095 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2732579 (UMLS CUI [9,3])
Organ Transplantation | Exception Keratoplasty | Exception Hair transplant procedure | Exception Skin Transplantation
Item
participant received an organ transplant (other than cornea or hair transplant or skin graft)
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0010042 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0191626 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0037297 (UMLS CUI [4,2])
Laboratory test result abnormal Study Protocol
Item
participants have key protocol defined laboratory abnormalities
boolean
C0438215 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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