ID

39129

Beschreibung

DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C); ODM derived from: https://clinicaltrials.gov/show/NCT01743521

Link

https://clinicaltrials.gov/show/NCT01743521

Stichworte

Versionen (2)
  1. 03.12.19 03.12.19 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

3. Dezember 2019

DOI

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Eligibility Early Chronic Hepatitis C NCT01743521

Englisch

Eligibility Early Chronic Hepatitis C NCT01743521

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written, informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. hcv genotype 1 infection
Beschreibung

Hepatitis C virus genotype 1 Infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3532919
UMLS CUI [1,2]
C3714514
3. quantifiable hcv rna at screening and baseline (>10,000 iu/ml)
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
4. recent hepatitis c infection with an estimated duration of infection >6 months and ≤
Beschreibung

Hepatitis C Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0449238
18 months defined as a) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) documented anti-hcv antibody negative or hcv rna negative within the 24 months prior to anti-hcv antibody positive result or b) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the 12 months prior to first positive hcv antibody or hcv rna with no other cause of acute hepatitis identifiable
Beschreibung

Hepatitis C Antibodies | Hepatitis C RNA positive | Hepatitis C antibody negative | Hepatitis C RNA negative | Hepatitis | Jaundice | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0166049
UMLS CUI [2]
C0855842
UMLS CUI [3]
C0853904
UMLS CUI [4]
C0855841
UMLS CUI [5]
C0019158
UMLS CUI [6]
C2010848
UMLS CUI [7]
C0151905
5. compensated liver disease (child-pugh a)
Beschreibung

Compensated liver disease Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
6. negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
Beschreibung

Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
7. if heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after rbv therapy has ended. note: hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. as of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
Beschreibung

Childbearing Potential Sexually active Contraceptive methods Quantity | Gender Without Vasectomy | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Contraceptive methods Except Hormonal contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0042387
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0332300
UMLS CUI [5,3]
C2985296
8. subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
Beschreibung

Patient's condition stable Physical Examination | Patient's condition stable Medical History | Patient's condition stable Vital signs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1282982
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1282982
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1282982
UMLS CUI [3,2]
C0518766
9. adequate english to provide written, informed consent and to provide reliable responses to the study interview
Beschreibung

Language skills English | Informed Consent | Patient interview

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0683518
additional inclusion criteria for hiv positive individuals
Beschreibung

Inclusion criteria Patients HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0019699
confirmed hiv infection > 6 months duration
Beschreibung

HIV Infection Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0449238
cd4 > 200 cells/mm3 and hiv < 50 c/ml on stable art at least 3 months prior to treatment
Beschreibung

CD4 Count determination | HIV viral load | Antiretroviral therapy Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0243009
UMLS CUI [2]
C1168369
UMLS CUI [3,1]
C1963724
UMLS CUI [3,2]
C0205360
or
Beschreibung

ID.14

Datentyp

boolean

cd4 >= 500 cells/mm3 and hiv vl < 100,000 not on art
Beschreibung

CD4 Count determination | HIV viral load | Antiretroviral therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0243009
UMLS CUI [2]
C1168369
UMLS CUI [3,1]
C1963724
UMLS CUI [3,2]
C0332197
if on art must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( tdf), lamivudine ( 3tc), emtricitabine (ftc), efavirenz (efv), abacavir (abc), raltegravir (ral), etravirine (etv), rilpivirine (ril), ritonavir boosted atazanavir (r/atz) * combination must be supported by current hiv treatment guidelines
Beschreibung

Antiretroviral therapy | Combined Modality Therapy | Tenofovir | Lamivudine | emtricitabine | efavirenz | abacavir | raltegravir | etravirine | Rilpivirine | Atazanavir+Ritonavir

Datentyp

boolean

Alias
UMLS CUI [1]
C1963724
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0384228
UMLS CUI [4]
C0209738
UMLS CUI [5]
C0909839
UMLS CUI [6]
C0674428
UMLS CUI [7]
C0663655
UMLS CUI [8]
C1871526
UMLS CUI [9]
C1456409
UMLS CUI [10]
C1566826
UMLS CUI [11]
C1977391
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
Beschreibung

Study Subject Participation Status | Follow-up Unlikely | Collection of blood specimen Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0750558
UMLS CUI [3,1]
C0005834
UMLS CUI [3,2]
C0558080
current injecting drug use (any injecting within previous 4 weeks)
Beschreibung

Injecting drug user

Datentyp

boolean

Alias
UMLS CUI [1]
C0556025
standard exclusions to peg-interferon (peg-ifn), ribavirin (rbv) and telaprevir (tpv) therapy
Beschreibung

PEGINTERFERON | Ribavirin | telaprevir

Datentyp

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2]
C0035525
UMLS CUI [3]
C1876229
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Ähnliche Modelle

Eligibility Early Chronic Hepatitis C NCT01743521

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Hepatitis C virus genotype 1 Infection
Item
2. hcv genotype 1 infection
boolean
C3532919 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Hepatitis C virus RNA assay
Item
3. quantifiable hcv rna at screening and baseline (>10,000 iu/ml)
boolean
C1272251 (UMLS CUI [1])
Hepatitis C Duration
Item
4. recent hepatitis c infection with an estimated duration of infection >6 months and ≤
boolean
C0019196 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hepatitis C Antibodies | Hepatitis C RNA positive | Hepatitis C antibody negative | Hepatitis C RNA negative | Hepatitis | Jaundice | Alanine aminotransferase increased
Item
18 months defined as a) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) documented anti-hcv antibody negative or hcv rna negative within the 24 months prior to anti-hcv antibody positive result or b) i) first anti-hcv antibody or hcv rna positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or alt> 10 x uln) within the 12 months prior to first positive hcv antibody or hcv rna with no other cause of acute hepatitis identifiable
boolean
C0166049 (UMLS CUI [1])
C0855842 (UMLS CUI [2])
C0853904 (UMLS CUI [3])
C0855841 (UMLS CUI [4])
C0019158 (UMLS CUI [5])
C2010848 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
Compensated liver disease Child-Pugh Classification
Item
5. compensated liver disease (child-pugh a)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Pregnancy test negative
Item
6. negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
boolean
C0427780 (UMLS CUI [1])
Childbearing Potential Sexually active Contraceptive methods Quantity | Gender Without Vasectomy | Gender Partner Childbearing Potential | Gender Contraceptive methods Quantity | Contraceptive methods Except Hormonal contraception
Item
7. if heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after rbv therapy has ended. note: hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. as of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0042387 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0700589 (UMLS CUI [5,1])
C0332300 (UMLS CUI [5,2])
C2985296 (UMLS CUI [5,3])
Patient's condition stable Physical Examination | Patient's condition stable Medical History | Patient's condition stable Vital signs
Item
8. subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
boolean
C1282982 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1282982 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1282982 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
Language skills English | Informed Consent | Patient interview
Item
9. adequate english to provide written, informed consent and to provide reliable responses to the study interview
boolean
C1145677 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C0683518 (UMLS CUI [3])
Inclusion criteria Patients HIV Seropositivity
Item
additional inclusion criteria for hiv positive individuals
boolean
C1512693 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0019699 (UMLS CUI [1,3])
HIV Infection Duration
Item
confirmed hiv infection > 6 months duration
boolean
C0019693 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
CD4 Count determination | HIV viral load | Antiretroviral therapy Stable
Item
cd4 > 200 cells/mm3 and hiv < 50 c/ml on stable art at least 3 months prior to treatment
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
ID.14
Item
or
boolean
CD4 Count determination | HIV viral load | Antiretroviral therapy Absent
Item
cd4 >= 500 cells/mm3 and hiv vl < 100,000 not on art
boolean
C0243009 (UMLS CUI [1])
C1168369 (UMLS CUI [2])
C1963724 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Antiretroviral therapy | Combined Modality Therapy | Tenofovir | Lamivudine | emtricitabine | efavirenz | abacavir | raltegravir | etravirine | Rilpivirine | Atazanavir+Ritonavir
Item
if on art must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( tdf), lamivudine ( 3tc), emtricitabine (ftc), efavirenz (efv), abacavir (abc), raltegravir (ral), etravirine (etv), rilpivirine (ril), ritonavir boosted atazanavir (r/atz) * combination must be supported by current hiv treatment guidelines
boolean
C1963724 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0384228 (UMLS CUI [3])
C0209738 (UMLS CUI [4])
C0909839 (UMLS CUI [5])
C0674428 (UMLS CUI [6])
C0663655 (UMLS CUI [7])
C1871526 (UMLS CUI [8])
C1456409 (UMLS CUI [9])
C1566826 (UMLS CUI [10])
C1977391 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Follow-up Unlikely | Collection of blood specimen Unwilling
Item
individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
boolean
C2348568 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
C0005834 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Injecting drug user
Item
current injecting drug use (any injecting within previous 4 weeks)
boolean
C0556025 (UMLS CUI [1])
PEGINTERFERON | Ribavirin | telaprevir
Item
standard exclusions to peg-interferon (peg-ifn), ribavirin (rbv) and telaprevir (tpv) therapy
boolean
C0982327 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C1876229 (UMLS CUI [3])
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