ID

39576

Beschreibung

Interaction Between Paroxetine and Telaprevir; ODM derived from: https://clinicaltrials.gov/show/NCT01841502

Link

https://clinicaltrials.gov/show/NCT01841502

Stichworte

Versionen (2)
  1. 30.01.20 30.01.20 -
  2. 31.01.20 31.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C Infection NCT01841502

Englisch

Eligibility Hepatitis C Infection NCT01841502

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18 and not older than 65 years at screening.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject is able and willing to sign the informed consent form prior to screening evaluations.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subject has a chronic hcv infection with genotype 1.
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1148363
subject is eligible for telaprevir containing hcv treatment.
Beschreibung

Therapy HCV | Telaprevir

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C1876229
subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
Beschreibung

Paroxetine Dose Stable U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0070122
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
Beschreibung

Drug Allergy | Idiosyncrasy Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparation Excipient | Idiosyncrasy Pharmaceutical Preparation Excipient

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0231191
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0015237
pregnant female (as confirmed by a human chorionic gonadotropin (hcg) test performed less than 6 weeks before day -1) or breast-feeding female. female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. they must agree to take precautions in order to prevent a pregnancy throughout.
Beschreibung

Pregnancy HCG pregnancy test | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Hysterectomy | Bilateral tubal ligation | Intrauterine Devices | Sexual Abstinence | Barrier Contraception Double | Postmenopausal state Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0589114
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9,1]
C0232970
UMLS CUI [9,2]
C0449238
relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
Beschreibung

Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683141
inability to understand the nature and extent of the trial and the procedures required.
Beschreibung

Study Protocol Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
participation in a drug trial within 60 days prior to the first dose of telaprevir.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
Beschreibung

Pharmaceutical Preparation concomitant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521115
hemoglobin < 12 g/dl (females) or < 13 g/dl (males) (7.4 respectively 8.0 mm).
Beschreibung

Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
poor- or ultrarapid metabolizer cyp2d6 (based on genetic testing)
Beschreibung

CYP2D6 poor metaboliser status Genetic testing | CYP2D6 ultrarapid metaboliser status Genetic testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3888904
UMLS CUI [1,2]
C0679560
UMLS CUI [2,1]
C3203681
UMLS CUI [2,2]
C0679560
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Ähnliche Modelle

Eligibility Hepatitis C Infection NCT01841502

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18 and not older than 65 years at screening.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject is able and willing to sign the informed consent form prior to screening evaluations.
boolean
C0021430 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
subject has a chronic hcv infection with genotype 1.
boolean
C0524910 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
Therapy HCV | Telaprevir
Item
subject is eligible for telaprevir containing hcv treatment.
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C1876229 (UMLS CUI [2])
Paroxetine Dose Stable U/day
Item
subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
boolean
C0070122 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Drug Allergy | Idiosyncrasy Pharmaceutical Preparations | Hypersensitivity Pharmaceutical Preparation Excipient | Idiosyncrasy Pharmaceutical Preparation Excipient
Item
documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
boolean
C0013182 (UMLS CUI [1])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0231191 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Pregnancy HCG pregnancy test | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Hysterectomy | Bilateral tubal ligation | Intrauterine Devices | Sexual Abstinence | Barrier Contraception Double | Postmenopausal state Duration
Item
pregnant female (as confirmed by a human chorionic gonadotropin (hcg) test performed less than 6 weeks before day -1) or breast-feeding female. female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. they must agree to take precautions in order to prevent a pregnancy throughout.
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0020699 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0232970 (UMLS CUI [9,1])
C0449238 (UMLS CUI [9,2])
Condition Interferes with Drug absorption | Condition Interferes with Drug distribution | Condition Interferes with Drug metabolism | Condition Interferes with Drug elimination
Item
relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
Study Protocol Comprehension Unable
Item
inability to understand the nature and extent of the trial and the procedures required.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a drug trial within 60 days prior to the first dose of telaprevir.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pharmaceutical Preparation concomitant
Item
use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
boolean
C0013227 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Hemoglobin measurement | Gender
Item
hemoglobin < 12 g/dl (females) or < 13 g/dl (males) (7.4 respectively 8.0 mm).
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
CYP2D6 poor metaboliser status Genetic testing | CYP2D6 ultrarapid metaboliser status Genetic testing
Item
poor- or ultrarapid metabolizer cyp2d6 (based on genetic testing)
boolean
C3888904 (UMLS CUI [1,1])
C0679560 (UMLS CUI [1,2])
C3203681 (UMLS CUI [2,1])
C0679560 (UMLS CUI [2,2])
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