ID

17526

Beschreibung

Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137); ODM derived from: https://clinicaltrials.gov/show/NCT00686517

Link

https://clinicaltrials.gov/show/NCT00686517

Stichworte

Versionen (1)
  1. 21.09.16 21.09.16 -
Hochgeladen am

21. September 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00686517

Englisch

Eligibility Hepatitis C NCT00686517

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with acute hepatitis c virus (hcv).
Beschreibung

Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019196
normal and elevated serum alanine transferase (alt) levels
Beschreibung

Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
positive serum hcv-rna.
Beschreibung

HCV viral load Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
aged between 18 and 65 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
Beschreibung

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Fertility Contraceptive methods | Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0035525
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
liver disease unrelated to hcv infection
Beschreibung

Liver disease Relationship Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0019196
hemoglobin (hgb) <12g/dl in women and <13g/dl in men; white blood cells (wbc) <3,000/ul; platelets (plts) <100,000/ul
Beschreibung

Hemoglobin | Gender | White Blood Cell Count procedure | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0032181
women with ongoing pregnancy or who are breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of severe psychiatric disease, especially depression
Beschreibung

Mental disorders Severe | Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0011581
history of neurologic disease, especially epilepsy
Beschreibung

nervous system disorder | Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
history or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
Beschreibung

Heart Disease Severe Symptoms Evidence | Gastrointestinal Disease Severe | Kidney Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C3887511
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
positive anti-human immunodeficiency virus (hiv) antibodies
Beschreibung

HIV antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0920548
positive anti-nuclear antibodies (ana) and/or anti-smooth muscle antibody (asma) (>1/80)
Beschreibung

Anti-nuclear factor positive | Smooth muscle antibody Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0151480
UMLS CUI [2,1]
C0369998
UMLS CUI [2,2]
C1514241
positive hepatitis b surface antigen (hbsag)
Beschreibung

Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
history of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
Beschreibung

Antineoplastic Therapy Systemic | Biological Response Modifier Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0005527
history or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
Beschreibung

Illness Severe Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate | Drug addict | methadone treatment | Thalassemia | Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
UMLS CUI [3]
C0700285
UMLS CUI [4]
C0746569
UMLS CUI [5]
C0039730
UMLS CUI [6]
C0011946
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Ähnliche Modelle

Eligibility Hepatitis C NCT00686517

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C
Item
diagnosed with acute hepatitis c virus (hcv).
boolean
C0019196 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
normal and elevated serum alanine transferase (alt) levels
boolean
C0201836 (UMLS CUI [1])
HCV viral load Positive
Item
positive serum hcv-rna.
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Age
Item
aged between 18 and 65 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Fertility Contraceptive methods | Ribavirin
Item
negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0015895 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0035525 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Liver disease Relationship Hepatitis C
Item
liver disease unrelated to hcv infection
boolean
C0023895 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hemoglobin | Gender | White Blood Cell Count procedure | Platelet Count measurement
Item
hemoglobin (hgb) <12g/dl in women and <13g/dl in men; white blood cells (wbc) <3,000/ul; platelets (plts) <100,000/ul
boolean
C0019046 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or who are breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Severe | Depressive disorder
Item
history of severe psychiatric disease, especially depression
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011581 (UMLS CUI [2])
nervous system disorder | Epilepsy
Item
history of neurologic disease, especially epilepsy
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Heart Disease Severe Symptoms Evidence | Gastrointestinal Disease Severe | Kidney Disease Severe
Item
history or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C3887511 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
HIV antibody positive
Item
positive anti-human immunodeficiency virus (hiv) antibodies
boolean
C0920548 (UMLS CUI [1])
Anti-nuclear factor positive | Smooth muscle antibody Positive
Item
positive anti-nuclear antibodies (ana) and/or anti-smooth muscle antibody (asma) (>1/80)
boolean
C0151480 (UMLS CUI [1])
C0369998 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Hepatitis B surface antigen positive
Item
positive hepatitis b surface antigen (hbsag)
boolean
C0149709 (UMLS CUI [1])
Antineoplastic Therapy Systemic | Biological Response Modifier Therapy
Item
history of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
boolean
C2346834 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0005527 (UMLS CUI [2])
Illness Severe Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate | Drug addict | methadone treatment | Thalassemia | Dialysis
Item
history or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
boolean
C0221423 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0700285 (UMLS CUI [3])
C0746569 (UMLS CUI [4])
C0039730 (UMLS CUI [5])
C0011946 (UMLS CUI [6])
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