ID

39727

Beschreibung

Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059); ODM derived from: https://clinicaltrials.gov/show/NCT01606800

Link

https://clinicaltrials.gov/show/NCT01606800

Stichworte

Versionen (1)
  1. 13.02.20 13.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

13. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01606800

Englisch

Eligibility Hepatitis C, Chronic NCT01606800

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant is ≥40 kg and ≤120 kg weight
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
Beschreibung

Study Subject Contraceptive methods | Study Subject Partner Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0700589
previously documented chc genotype 4 infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
liver biopsy or fibrotest and fibroscan with histology consistent with chc and no other etiology and with hepatic fibrosis scores (f0, f1, f2, f3).
Beschreibung

Biopsy of liver | FibroTest Score Measurement | Fibroscan | Histology Consistent with Chronic Hepatitis C | Etiology Other Absent | Liver Fibrosis Score

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C3642160
UMLS CUI [3]
C4522043
UMLS CUI [4,1]
C0344441
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C0524910
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0205394
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0239946
UMLS CUI [6,2]
C1954437
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus
Beschreibung

Human immunodeficiency virus (HIV) coinfection | HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
treatment for hepatitis c with any investigational medication
Beschreibung

Therapeutic procedure Hepatitis C | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0013230
treatment with any investigational drug within 30 days of the screening visit
Beschreibung

Investigational New Drugs Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
Beschreibung

Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4]
C0019151
autoimmune hepatitis or a history of autoimmune disease
Beschreibung

Hepatitis, Autoimmune | Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2]
C0004364
hepatic fibrosis score f4
Beschreibung

Liver Fibrosis Score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0239946
UMLS CUI [1,2]
C1954437
severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
Beschreibung

Heart Disease Severe Pre-existing | Heart Disease Unstable | Heart Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
autoimmune hepatitis or a history of autoimmune disease
Beschreibung

Hepatitis, Autoimmune | Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
UMLS CUI [2]
C0004364
thyroid disease uncontrolled with conventional treatment
Beschreibung

Thyroid Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0205318
epilepsy and/or compromised central nervous system (cns) function
Beschreibung

Epilepsy | Central nervous system function Impaired

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0683212
UMLS CUI [2,2]
C0221099
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Ähnliche Modelle

Eligibility Hepatitis C, Chronic NCT01606800

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
participant is ≥40 kg and ≤120 kg weight
boolean
C0005910 (UMLS CUI [1])
Study Subject Contraceptive methods | Study Subject Partner Contraceptive methods
Item
participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
boolean
C0681850 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Chronic Hepatitis C Genotype
Item
previously documented chc genotype 4 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Biopsy of liver | FibroTest Score Measurement | Fibroscan | Histology Consistent with Chronic Hepatitis C | Etiology Other Absent | Liver Fibrosis Score
Item
liver biopsy or fibrotest and fibroscan with histology consistent with chc and no other etiology and with hepatic fibrosis scores (f0, f1, f2, f3).
boolean
C0193388 (UMLS CUI [1])
C3642160 (UMLS CUI [2])
C4522043 (UMLS CUI [3])
C0344441 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0524910 (UMLS CUI [4,3])
C0015127 (UMLS CUI [5,1])
C0205394 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0239946 (UMLS CUI [6,1])
C1954437 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Human immunodeficiency virus (HIV) coinfection | HBV coinfection
Item
co-infected with the human immunodeficiency virus (hiv) or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Therapeutic procedure Hepatitis C | Investigational New Drugs
Item
treatment for hepatitis c with any investigational medication
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Investigational New Drugs Recent
Item
treatment with any investigational drug within 30 days of the screening visit
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Decompensated liver disease | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
Hepatitis, Autoimmune | Autoimmune Disease
Item
autoimmune hepatitis or a history of autoimmune disease
boolean
C0241910 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Liver Fibrosis Score
Item
hepatic fibrosis score f4
boolean
C0239946 (UMLS CUI [1,1])
C1954437 (UMLS CUI [1,2])
Heart Disease Severe Pre-existing | Heart Disease Unstable | Heart Disease Uncontrolled
Item
severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Hepatitis, Autoimmune | Autoimmune Diseases
Item
autoimmune hepatitis or a history of autoimmune disease
boolean
C0241910 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
Thyroid Disease Uncontrolled
Item
thyroid disease uncontrolled with conventional treatment
boolean
C0040128 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Epilepsy | Central nervous system function Impaired
Item
epilepsy and/or compromised central nervous system (cns) function
boolean
C0014544 (UMLS CUI [1])
C0683212 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
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