ID

29699

Beschreibung

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy and Hepatitis C Infected Male Patients (MK-3281-002)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00635804

Link

https://clinicaltrials.gov/show/NCT00635804

Stichworte

Versionen (1)
  1. 13.04.18 13.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. April 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hepatitis C NCT00635804

Englisch

Eligibility Hepatitis C NCT00635804

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Beschreibung

Good health | Medical History | Physical Examination | Vital signs | Laboratory Tests Safety

Datentyp

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0518766
UMLS CUI [5,1]
C0022885
UMLS CUI [5,2]
C0036043
subject has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Beschreibung

ECG normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522054
subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Beschreibung

Partner Childbearing Potential | Study Subject Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C3831118
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0700589
patient has a clinical diagnosis of chronic hcv infection.
Beschreibung

Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0524910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of stroke, chronic seizures, or major neurological disorder
Beschreibung

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Beschreibung

Endocrine System Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system

Datentyp

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0080276
subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
Beschreibung

Neoplastic disease | Leukemia | Lymphoma | Melanoma malignant | Myeloproliferative disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2]
C0023418
UMLS CUI [3]
C0024299
UMLS CUI [4,1]
C0025202
UMLS CUI [4,2]
C0205282
UMLS CUI [5]
C0027022
subject has positive hepatitis b surface antigen (or other evidence of active hepatitis b infection) at the prescreening (study) visit
Beschreibung

Hepatitis B surface antigen positive | Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019163
for healthy panel, subject has evidence of chronic hepatitis c virus infection at the prescreening (study) visit
Beschreibung

Group Healthy | Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0524910
subject has a history of documented hivinfection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatitis C NCT00635804

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Good health | Medical History | Physical Examination | Vital signs | Laboratory Tests Safety
Item
subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
boolean
C3813622 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0022885 (UMLS CUI [5,1])
C0036043 (UMLS CUI [5,2])
ECG normal
Item
subject has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
boolean
C0522054 (UMLS CUI [1])
Partner Childbearing Potential | Study Subject Contraceptive methods
Item
subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
boolean
C0682323 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Hepatitis C, Chronic
Item
patient has a clinical diagnosis of chronic hcv infection.
boolean
C0524910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
subject has a history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Endocrine System Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system
Item
subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
boolean
C0014130 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0080276 (UMLS CUI [8])
Neoplastic disease | Leukemia | Lymphoma | Melanoma malignant | Myeloproliferative disease
Item
subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
boolean
C1882062 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0025202 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
C0027022 (UMLS CUI [5])
Hepatitis B surface antigen positive | Hepatitis B
Item
subject has positive hepatitis b surface antigen (or other evidence of active hepatitis b infection) at the prescreening (study) visit
boolean
C0149709 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Group Healthy | Hepatitis C, Chronic
Item
for healthy panel, subject has evidence of chronic hepatitis c virus infection at the prescreening (study) visit
boolean
C0441833 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2])
HIV Infection
Item
subject has a history of documented hivinfection
boolean
C0019693 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video