ID

39652

Beschreibung

A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105); ODM derived from: https://clinicaltrials.gov/show/NCT01756079

Link

https://clinicaltrials.gov/show/NCT01756079

Stichworte

Versionen (1)
  1. 08.02.20 08.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01756079

Englisch

Eligibility Hepatitis C NCT01756079

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
weight between 40 kg and 125 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
documented chc genotype 1 infection
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
previous course of treatment with soc (pegifn-2a or pegifn-2b + rbv) with a documented non-response
Beschreibung

Prior Therapy Standard of Care | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin | Response Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2936643
UMLS CUI [2,1]
C0391001
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0035525
UMLS CUI [3,1]
C0796545
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0035525
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0332268
documented diagnosis of cirrhosis
Beschreibung

Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
no evidence of hepatocellular carcinoma (hcc) by ultrasound
Beschreibung

Liver carcinoma Absent Ultrasonography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0041618
participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)
Beschreibung

Study Subject Contraceptive Agents Quantity | Partner Contraceptive Agents Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0009871
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0009871
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

HIV coinfection | HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
use of any investigational drugs within 30 days prior to study enrollment
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
Beschreibung

Study Subject Participation Status | Clinical Trial | Intention Participation Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C1283828
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0008976
evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. only participants with large (f3) esophageal varices, as determined in an esophagogastroduodenoscopy (egd) performed within the past 12 months according to international guidelines will be excluded.
Beschreibung

Decompensated liver disease | Ascites | Hepatic Encephalopathy | Esophageal Varices Large Grade | Esophageal Varices Esophagogastroduodenoscopy

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4,1]
C0014867
UMLS CUI [4,2]
C0549177
UMLS CUI [4,3]
C0441800
UMLS CUI [5,1]
C0014867
UMLS CUI [5,2]
C0079304
clinically significant ocular examination findings
Beschreibung

On examination - eye findings Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0437530
UMLS CUI [1,2]
C2826293
pre-existing significant psychiatric condition(s)
Beschreibung

Psychiatric problems Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306597
UMLS CUI [1,2]
C2347662
clinical diagnosis of active or recent substance abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
Beschreibung

Malignant Neoplasms | Malignant Neoplasms Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
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Ähnliche Modelle

Eligibility Hepatitis C NCT01756079

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight
Item
weight between 40 kg and 125 kg
boolean
C0005910 (UMLS CUI [1])
Chronic Hepatitis C Genotype
Item
documented chc genotype 1 infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Prior Therapy Standard of Care | Peginterferon alfa-2a plus Ribavirin | Peginterferon alfa-2b plus Ribavirin | Response Lacking
Item
previous course of treatment with soc (pegifn-2a or pegifn-2b + rbv) with a documented non-response
boolean
C1514463 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0391001 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0035525 (UMLS CUI [2,3])
C0796545 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
C1704632 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Liver Cirrhosis
Item
documented diagnosis of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Liver carcinoma Absent Ultrasonography
Item
no evidence of hepatocellular carcinoma (hcc) by ultrasound
boolean
C2239176 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Study Subject Contraceptive Agents Quantity | Partner Contraceptive Agents Quantity
Item
participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)
boolean
C0681850 (UMLS CUI [1,1])
C0009871 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0009871 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
HIV coinfection | HBV coinfection
Item
co-infection with human immunodeficiency virus (hiv) or hepatitis b virus
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Investigational New Drugs
Item
use of any investigational drugs within 30 days prior to study enrollment
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial | Intention Participation Clinical Trial
Item
participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1283828 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Esophageal Varices Large Grade | Esophageal Varices Esophagogastroduodenoscopy
Item
evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. only participants with large (f3) esophageal varices, as determined in an esophagogastroduodenoscopy (egd) performed within the past 12 months according to international guidelines will be excluded.
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C0014867 (UMLS CUI [4,1])
C0549177 (UMLS CUI [4,2])
C0441800 (UMLS CUI [4,3])
C0014867 (UMLS CUI [5,1])
C0079304 (UMLS CUI [5,2])
On examination - eye findings Clinical Significance
Item
clinically significant ocular examination findings
boolean
C0437530 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Psychiatric problems Pre-existing
Item
pre-existing significant psychiatric condition(s)
boolean
C1306597 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Substance Use Disorders
Item
clinical diagnosis of active or recent substance abuse
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms Suspected | Exception Carcinoma in Situ Treated | Exception Basal cell carcinoma Treated
Item
evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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