ID

39650

Beschreibung

Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01718158

Link

https://clinicaltrials.gov/show/NCT01718158

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 NCT01718158

Englisch

Eligibility Hepatitis C NCT01718158

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients chronically infected with hcv genotype-1b
Beschreibung

Chronic Hepatitis C Genotype

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
Beschreibung

Therapy naive | Recurrent disease Post Treatment completed

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0580352
hcv rna viral load ≥100,000 iu/ml at screening
Beschreibung

Hepatitis C virus RNA Viral load measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0369335
UMLS CUI [1,2]
C1261478
patients with compensated cirrhosis are permitted
Beschreibung

Compensated cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C1608426
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection with hepatitis c virus (hcv) other than genotype-1b
Beschreibung

Hepatitis C | Exception Genotype determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533728
positive hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)-1/hiv-2 antibody test at screening
Beschreibung

Hepatitis B surface antigen positive | Human immunodeficiency virus type 1 antibody Positive | Human immunodeficiency virus, type II antibody Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0369497
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0369500
UMLS CUI [3,2]
C1514241
evidence of chronic liver disease caused by diseases other than chronic hcv infection
Beschreibung

Chronic liver disease caused by Disease | Exception Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
Beschreibung

Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis

Datentyp

boolean

Alias
UMLS CUI [1]
C0333106
UMLS CUI [2]
C0019151
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0012798
UMLS CUI [4,1]
C0003962
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0034115
current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
Beschreibung

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Beschreibung

Decompensated cirrhosis of liver Diagnostic radiologic examination | Decompensated cirrhosis of liver Biopsy | Decompensated cirrhosis of liver Clinical examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1619727
UMLS CUI [1,2]
C0043299
UMLS CUI [2,1]
C1619727
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C1619727
UMLS CUI [3,2]
C1456356
laboratory values:
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
1. hemoglobin <12.0 g/dl (males) or <11.0 g/dl (females)
Beschreibung

Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
2. platelets <90,000/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
3. total serum bilirubin ≥2 mg/dl (unless due to gilbert's disease)
Beschreibung

Serum total bilirubin measurement | Exception Due to Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017551
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Ähnliche Modelle

Eligibility Hepatitis C NCT01718158

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype
Item
patients chronically infected with hcv genotype-1b
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Recurrent disease Post Treatment completed
Item
naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
boolean
C0919936 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
Hepatitis C virus RNA Viral load measurement
Item
hcv rna viral load ≥100,000 iu/ml at screening
boolean
C0369335 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
Compensated cirrhosis
Item
patients with compensated cirrhosis are permitted
boolean
C1608426 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Exception Genotype determination
Item
infection with hepatitis c virus (hcv) other than genotype-1b
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Hepatitis B surface antigen positive | Human immunodeficiency virus type 1 antibody Positive | Human immunodeficiency virus, type II antibody Positive
Item
positive hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)-1/hiv-2 antibody test at screening
boolean
C0149709 (UMLS CUI [1])
C0369497 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0369500 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Chronic liver disease caused by Disease | Exception Chronic Hepatitis C
Item
evidence of chronic liver disease caused by diseases other than chronic hcv infection
boolean
C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis
Item
current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0003962 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0012798 (UMLS CUI [3,3])
C0003962 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0034115 (UMLS CUI [4,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Decompensated cirrhosis of liver Diagnostic radiologic examination | Decompensated cirrhosis of liver Biopsy | Decompensated cirrhosis of liver Clinical examination
Item
current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
boolean
C1619727 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1619727 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1619727 (UMLS CUI [3,1])
C1456356 (UMLS CUI [3,2])
Laboratory Results
Item
laboratory values:
boolean
C1254595 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
1. hemoglobin <12.0 g/dl (males) or <11.0 g/dl (females)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
2. platelets <90,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
3. total serum bilirubin ≥2 mg/dl (unless due to gilbert's disease)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
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