ID

13830

Description

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Keywords

Versions (1)
  1. 3/10/16 3/10/16 -
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CC BY-NC 3.0

Uploaded on

March 10, 2016

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Demographic Date and Informed Consent Recording

English

VX-950HPC3006 Demographic Date and Informed Consent Recording

1 forms  
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Was the actual date of birth recorded in IWRS?
Description

If no, provide age at informed consent and indicate the parts of the date that were not recorded

Data type

boolean

Alias
UMLS CUI [1]
C0421451
Subject signed informed consent on
Description

Date of informed consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Did the subject consent to sampling for DNA research?
Description

Consent to sampling for DNA research

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0444245
Did the subject consent to long term storage and exploratory analysis of blood samples as described in the ICF?
Description

Consent to long term storage and exploratory analysis of blood samples

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0443252
UMLS CUI [1,4]
C0178913
UMLS CUI [1,5]
C0936012
Sex at birth
Description

Sex at birth

Data type

integer

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C2599577
If female, is this a female of childbearing potential?
Description

Childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Does the subject smoke?
Description

Light = not more than 10 cigarettes or 2 cigars or 2 pipes per day Moderate = not more than 11-25 cigarettes or 3-5 cigars or 3-5 pipes per day Heavy = more than 25 cigarettes or 5 cigars or 5 pipes per day

Data type

integer

Alias
UMLS CUI [1]
C1519386
Does the subject drink alcohol? If yes, please state the number of units/week where applicable
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
Beer consumption
Description

Beer consumption

Data type

text

Alias
UMLS CUI [1]
C2107808
Wine consumption
Description

Wine consumption

Data type

text

Alias
UMLS CUI [1]
C2203276
Distilled spirits consumption
Description

Distilled spirits consumption

Data type

text

Does the subject use recreational drugs?
Description

If yes, please specify

Data type

boolean

Alias
UMLS CUI [1]
C0013146
Amphetamine
Description

Amphetamine

Data type

boolean

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

Barbiturates

Data type

boolean

Alias
UMLS CUI [1]
C0004745
Benzodiazepines
Description

Benzodiazepines

Data type

boolean

Alias
UMLS CUI [1]
C0005064
Cocaine
Description

Cocaine

Data type

boolean

Alias
UMLS CUI [1]
C0009170
Cannabinoids
Description

Cannabinoids

Data type

boolean

Alias
UMLS CUI [1]
C0006864
Opioids
Description

Opioids

Data type

boolean

Alias
UMLS CUI [1]
C0242402
Clinical Trial History
Description

Clinical Trial History

Has the subject previously participated in a Tibotec sponsored trial?
Description

Previous participation in a trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Subject Identification
Description

Subject Identification

Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Site ID
Description

Site ID

Data type

text

Alias
UMLS CUI [1]
C2826692
Country code
Description

Country code

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0454664
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Similar models

VX-950HPC3006 Demographic Date and Informed Consent Recording

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Was the actual date of birth recorded in IWRS?
Item
Was the actual date of birth recorded in IWRS?
boolean
C0421451 (UMLS CUI [1])
Date of informed consent
Item
Subject signed informed consent on
date
C2985782 (UMLS CUI [1])
Consent to sampling for DNA research
Item
Did the subject consent to sampling for DNA research?
boolean
C0021430 (UMLS CUI [1,1])
C0444245 (UMLS CUI [1,2])
Consent to long term storage and exploratory analysis of blood samples
Item
Did the subject consent to long term storage and exploratory analysis of blood samples as described in the ICF?
boolean
C0021430 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
C0936012 (UMLS CUI [1,5])
Item
Sex at birth
integer
C0079399 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Sex at birth
Code List
Sex at birth
CL Item
female (1)
CL Item
male (2)
Childbearing potential
Item
If female, is this a female of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
not allowed to ask per local regulations (1)
CL Item
hispanic or latino (2)
CL Item
not hispanic or not latino (3)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
not allowed to ask per local regulations (1)
CL Item
American Indian or Alaska Native (2)
CL Item
Asian (3)
CL Item
Black or African American (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
CL Item
White (6)
Item
Does the subject smoke?
integer
C1519386 (UMLS CUI [1])
Smoking status
Code List
Does the subject smoke?
CL Item
Light (1)
CL Item
Moderate (2)
CL Item
Heavy (3)
CL Item
No (4)
Alcohol consumption
Item
Does the subject drink alcohol? If yes, please state the number of units/week where applicable
boolean
C0001948 (UMLS CUI [1])
Beer consumption
Item
Beer consumption
text
C2107808 (UMLS CUI [1])
Wine consumption
Item
Wine consumption
text
C2203276 (UMLS CUI [1])
Distilled spirits consumption
Item
Distilled spirits consumption
text
Drug abuse
Item
Does the subject use recreational drugs?
boolean
C0013146 (UMLS CUI [1])
Amphetamine
Item
Amphetamine
boolean
C0002667 (UMLS CUI [1])
Barbiturates
Item
Barbiturates
boolean
C0004745 (UMLS CUI [1])
Benzodiazepines
Item
Benzodiazepines
boolean
C0005064 (UMLS CUI [1])
Cocaine
Item
Cocaine
boolean
C0009170 (UMLS CUI [1])
Cannabinoids
Item
Cannabinoids
boolean
C0006864 (UMLS CUI [1])
Opioids
Item
Opioids
boolean
C0242402 (UMLS CUI [1])
Item Group
Clinical Trial History
Previous participation in a trial
Item
Has the subject previously participated in a Tibotec sponsored trial?
boolean
C2348568 (UMLS CUI [1])
Item Group
Subject Identification
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Site ID
Item
Site ID
text
C2826692 (UMLS CUI [1])
Country code
Item
Country code
text
C0805701 (UMLS CUI [1,1])
C0454664 (UMLS CUI [1,2])
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