ID

40989

Description

VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.; ODM derived from: https://clinicaltrials.gov/show/NCT00903773

Link

https://clinicaltrials.gov/show/NCT00903773

Keywords

Versions (1)
  1. 6/8/20 6/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 8, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00903773

English

Eligibility Hepatitis C NCT00903773

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males are allowed and females of childbearing potential if adequate contraception is used. females of non-childbearing potential should be amenorrheal for at least 2 years, or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
Description

Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Absent | Amenorrhea Duration | Tubal Ligation | Total hysterectomy | Bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0002453
UMLS CUI [4,2]
C0449238
UMLS CUI [5]
C0520483
UMLS CUI [6]
C0677962
UMLS CUI [7]
C0278321
for participants with severe renal impairment: consistent with the disease process of chronic renal failure and associated symptoms, otherwise judged to be in good health in the opinion of the investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiogram (ecg), vital signs, and screening laboratory tests), with any concomitant medical conditions under stable medical control
Description

Renal Insufficiency Severe | Consistent with Chronic Kidney Failure Symptoms | General health good Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Laboratory Procedures | Comorbidity Under Control Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0332290
UMLS CUI [2,2]
C0022661
UMLS CUI [2,3]
C1457887
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C1261322
UMLS CUI [4]
C0031809
UMLS CUI [5]
C0262926
UMLS CUI [6]
C1623258
UMLS CUI [7]
C0518766
UMLS CUI [8]
C0022885
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C2911690
UMLS CUI [9,3]
C0205360
for participants with severe renal impairment: creatinine clearance < 30 ml/min (cockcroft-gault)
Description

Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
for healthy controls: healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ecg, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
Description

Healthy Control | Abnormality Absent Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Blood Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis

Data type

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1261322
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0262926
UMLS CUI [5]
C1623258
UMLS CUI [6]
C0518766
UMLS CUI [7,1]
C0005767
UMLS CUI [7,2]
C0428132
UMLS CUI [8]
C0005790
UMLS CUI [9]
C0018941
UMLS CUI [10]
C0042014
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of any illness (unrelated to renal impairment, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study medication to the participant. this may include but is not limited to: diabetes mellitus, history of relevant drug or food allergies
Description

Illness Interferes with Research results | Illness Investigational New Drugs At risk | Diabetes Mellitus | Drug Allergy | Food Allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0013182
UMLS CUI [5]
C0016470
history of cardiovascular or central nervous system disease
Description

Cardiovascular Disease | CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007682
history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
Description

Pathology Clinical Significance | Chronic disease of skin | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1290009
UMLS CUI [3]
C0004936
for subjects with severe renal impairment: history of renal transplant or renal carcinoma. participants with a history of renal carcinoma who have been cancer free for at least 5 years may be included
Description

Renal Insufficiency Severe | Kidney Transplantation | Renal carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0022671
UMLS CUI [3]
C1378703
for participants with severe renal impairment: participants with end stage renal disease (esrd) requiring dialysis
Description

Renal Insufficiency Severe | Chronic Kidney Failure Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0011946
for healthy controls: current use of prescription medication and regular treatment with over-the-counter medications
Description

Healthy Control | Prescription Drugs | Non-Prescription Drugs Regular

Data type

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2]
C0304227
UMLS CUI [3,1]
C0013231
UMLS CUI [3,2]
C0205272
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Similar models

Eligibility Hepatitis C NCT00903773

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Absent | Amenorrhea Duration | Tubal Ligation | Total hysterectomy | Bilateral oophorectomy
Item
males are allowed and females of childbearing potential if adequate contraception is used. females of non-childbearing potential should be amenorrheal for at least 2 years, or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral)
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0002453 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0520483 (UMLS CUI [5])
C0677962 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
Renal Insufficiency Severe | Consistent with Chronic Kidney Failure Symptoms | General health good Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Laboratory Procedures | Comorbidity Under Control Stable
Item
for participants with severe renal impairment: consistent with the disease process of chronic renal failure and associated symptoms, otherwise judged to be in good health in the opinion of the investigator on the basis of a medical evaluation (including a physical examination, medical history, electrocardiogram (ecg), vital signs, and screening laboratory tests), with any concomitant medical conditions under stable medical control
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332290 (UMLS CUI [2,1])
C0022661 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C1277245 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0031809 (UMLS CUI [4])
C0262926 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
C0518766 (UMLS CUI [7])
C0022885 (UMLS CUI [8])
C0009488 (UMLS CUI [9,1])
C2911690 (UMLS CUI [9,2])
C0205360 (UMLS CUI [9,3])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
for participants with severe renal impairment: creatinine clearance < 30 ml/min (cockcroft-gault)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Healthy Control | Abnormality Absent Evaluation | Physical Examination | Medical History | Electrocardiography | Vital signs | Blood Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis
Item
for healthy controls: healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ecg, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening
boolean
C2986479 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0005767 (UMLS CUI [7,1])
C0428132 (UMLS CUI [7,2])
C0005790 (UMLS CUI [8])
C0018941 (UMLS CUI [9])
C0042014 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Illness Interferes with Research results | Illness Investigational New Drugs At risk | Diabetes Mellitus | Drug Allergy | Food Allergy
Item
a history of any illness (unrelated to renal impairment, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study medication to the participant. this may include but is not limited to: diabetes mellitus, history of relevant drug or food allergies
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0013182 (UMLS CUI [4])
C0016470 (UMLS CUI [5])
Cardiovascular Disease | CNS disorder
Item
history of cardiovascular or central nervous system disease
boolean
C0007222 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
Pathology Clinical Significance | Chronic disease of skin | Mental disorders
Item
history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
boolean
C0677042 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1290009 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Renal Insufficiency Severe | Kidney Transplantation | Renal carcinoma
Item
for subjects with severe renal impairment: history of renal transplant or renal carcinoma. participants with a history of renal carcinoma who have been cancer free for at least 5 years may be included
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022671 (UMLS CUI [2])
C1378703 (UMLS CUI [3])
Renal Insufficiency Severe | Chronic Kidney Failure Requirement Dialysis
Item
for participants with severe renal impairment: participants with end stage renal disease (esrd) requiring dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
Healthy Control | Prescription Drugs | Non-Prescription Drugs Regular
Item
for healthy controls: current use of prescription medication and regular treatment with over-the-counter medications
boolean
C2986479 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0013231 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
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