ID

39645

Description

A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a + Ribavirin in Chronic Hepatitis C Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01567540

Link

https://clinicaltrials.gov/show/NCT01567540

Keywords

Versions (1)
  1. 2/7/20 2/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01567540

English

Eligibility Hepatitis C NCT01567540

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 and 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
for women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment
Description

Gender Contraceptive methods | Gender Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430057
patients naïve to prior hepatitis c treatment
Description

Therapy naive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
confirmed hcv infection, based on the presence of hcv antibodies and plasma viremia allowing a measure of the circulating viral load
Description

Hepatitis C | Hepatitis C Antibodies Present | Plasma Viremia | Viral load measurement allowing

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C0042749
UMLS CUI [4,1]
C1261478
UMLS CUI [4,2]
C0683607
infection with hcv genotype 1 or 4
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
intent of treatment alfa2 pegylated ifn-/ ribavirin
Description

Treatment intent PEGINTERFERON/RIBAVIRIN

Data type

boolean

Alias
UMLS CUI [1,1]
C1292734
UMLS CUI [1,2]
C1875630
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hbv infection
Description

Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0019163
hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
severe anemia (hb <7-8 g / dl)
Description

Anemia, severe | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0238644
UMLS CUI [2]
C0518015
renal failure (creatinine clearance <60 ml / min)
Description

Kidney Failure | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0373595
taking digoxin within 6 months of starting treatment.
Description

Digoxin

Data type

boolean

Alias
UMLS CUI [1]
C0012265
taking immunosuppressants within 6 months of starting treatment
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
history of serious hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin
Description

Allergic Reaction Serious Sitagliptin | Anaphylaxis | Angioedema

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1565750
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0002994
patients with type i and ii diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
pregnancy or absence of effective contraception
Description

Pregnancy | Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332197
a person deprived of liberty by judicial or administrative decision
Description

Person Deprivation Freedom

Data type

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
living conditions-suggesting an inability to track all scheduled visits by the protocol
Description

Compliance behavior Clinical Trial Visits Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0008952
UMLS CUI [1,4]
C1299582
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Similar models

Eligibility Hepatitis C NCT01567540

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 and 70 years
boolean
C0001779 (UMLS CUI [1])
Gender Contraceptive methods | Gender Urine pregnancy test negative
Item
for women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Therapy naive Hepatitis C
Item
patients naïve to prior hepatitis c treatment
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Hepatitis C | Hepatitis C Antibodies Present | Plasma Viremia | Viral load measurement allowing
Item
confirmed hcv infection, based on the presence of hcv antibodies and plasma viremia allowing a measure of the circulating viral load
boolean
C0019196 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0032105 (UMLS CUI [3,1])
C0042749 (UMLS CUI [3,2])
C1261478 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Hepatitis C Genotype
Item
infection with hcv genotype 1 or 4
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Treatment intent PEGINTERFERON/RIBAVIRIN
Item
intent of treatment alfa2 pegylated ifn-/ ribavirin
boolean
C1292734 (UMLS CUI [1,1])
C1875630 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hepatitis B
Item
hbv infection
boolean
C0019163 (UMLS CUI [1])
HIV Infection
Item
hiv infection
boolean
C0019693 (UMLS CUI [1])
Anemia, severe | Hemoglobin measurement
Item
severe anemia (hb <7-8 g / dl)
boolean
C0238644 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Kidney Failure | Creatinine clearance measurement
Item
renal failure (creatinine clearance <60 ml / min)
boolean
C0035078 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Digoxin
Item
taking digoxin within 6 months of starting treatment.
boolean
C0012265 (UMLS CUI [1])
Immunosuppressive Agents
Item
taking immunosuppressants within 6 months of starting treatment
boolean
C0021081 (UMLS CUI [1])
Allergic Reaction Serious Sitagliptin | Anaphylaxis | Angioedema
Item
history of serious hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin
boolean
C1527304 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1565750 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2])
C0002994 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type i and ii diabetes
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Pregnancy | Contraceptive methods Absent
Item
pregnancy or absence of effective contraception
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Person Deprivation Freedom
Item
a person deprived of liberty by judicial or administrative decision
boolean
C0027361 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
Compliance behavior Clinical Trial Visits Unable
Item
living conditions-suggesting an inability to track all scheduled visits by the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
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