ID

42481

Beschreibung

Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01687270

Link

https://clinicaltrials.gov/show/NCT01687270

Stichworte

Versionen (1)
  1. 17.07.21 17.07.21 -
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Gilead Sciences

Hochgeladen am

17. Juli 2021

DOI

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Creative Commons BY-NC 4.0
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Eligibility Recurrent Chronic Hepatitis C Virus NCT01687270

Englisch

Eligibility Recurrent Chronic Hepatitis C Virus NCT01687270

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with evidence of chronic hcv (all genotypes) documented pretransplantation
Beschreibung

evidence of chronic hcv (all genotypes) documented pretransplantation

Datentyp

boolean

hcv rna ≥ 10,000 iu/ml at screening
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/day 1 visit
Beschreibung

Absence of organ rejection as documented by recent post transplant liver biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018129
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1301725
UMLS CUI [1,4]
C0193388
UMLS CUI [1,5]
C0332185
liver transplant ≥ 6 months and ≤ 12 years prior to screening
Beschreibung

Liver transplant recipient

Datentyp

boolean

Alias
UMLS CUI [1]
C3811922
naive to all nucleotide/nucleoside treatments for chronic hcv infection
Beschreibung

No prior therapy with nucleotide/nucleoside treatments for chronic hcv infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1579410
UMLS CUI [1,3]
C0597107
UMLS CUI [1,4]
C0524910
UMLS CUI [1,5]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
multiorgan transplant that includes heart or lung recipient
Beschreibung

Multiorgan transplant | Heart transplant recipient | Lung transplant recipient

Datentyp

boolean

Alias
UMLS CUI [1]
C2029943
UMLS CUI [2]
C2063401
subjects with de novo or recurrent hepatocellular carcinoma(hcc) post transplant
Beschreibung

De novohepatocellular carcinoma | Recurrent hepatocellular carcinoma(hcc) post transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0861876
UMLS CUI [2,2]
C0023911
current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
Beschreibung

Current use of corticosteroids, prednisone equivalent daily dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0032952
UMLS CUI [1,4]
C0205163
UMLS CUI [1,5]
C0521116
infection with hepatitis b virus (hbv) or hiv at screening
Beschreibung

Hepatitis b virus surface antigen positive | HIV test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C1321876
UMLS CUI [2,2]
C1446409
current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
Beschreibung

Current, uncontrolled ascites | Variceal hemorrhage | Hepatic encephalopathy | Hepatorenal syndrome | Hepatopulmonary syndrome | Other signs of decompensated cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C0333106
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C0019151
UMLS CUI [3,2]
C0521116
UMLS CUI [4]
C0019212
UMLS CUI [5]
C0600452
UMLS CUI [6,1]
C1394798
UMLS CUI [6,2]
C0521116
UMLS CUI [6,3]
C0037088
UMLS CUI [6,4]
C0205394
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Ähnliche Modelle

Eligibility Recurrent Chronic Hepatitis C Virus NCT01687270

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
evidence of chronic hcv (all genotypes) documented pretransplantation
Item
subjects with evidence of chronic hcv (all genotypes) documented pretransplantation
boolean
Hepatitis C virus RNA assay
Item
hcv rna ≥ 10,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Absence of organ rejection as documented by recent post transplant liver biopsy
Item
absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/day 1 visit
boolean
C0018129 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1301725 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,5])
Liver transplant recipient
Item
liver transplant ≥ 6 months and ≤ 12 years prior to screening
boolean
C3811922 (UMLS CUI [1])
No prior therapy with nucleotide/nucleoside treatments for chronic hcv infection
Item
naive to all nucleotide/nucleoside treatments for chronic hcv infection
boolean
C1514463 (UMLS CUI [1,1])
C1579410 (UMLS CUI [1,2])
C0597107 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
C0332197 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Multiorgan transplant | Heart transplant recipient | Lung transplant recipient
Item
multiorgan transplant that includes heart or lung recipient
boolean
C2029943 (UMLS CUI [1])
C2063401 (UMLS CUI [2])
De novohepatocellular carcinoma | Recurrent hepatocellular carcinoma(hcc) post transplant
Item
subjects with de novo or recurrent hepatocellular carcinoma(hcc) post transplant
boolean
C2239176 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0861876 (UMLS CUI [2,1])
C0023911 (UMLS CUI [2,2])
Current use of corticosteroids, prednisone equivalent daily dose
Item
current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
boolean
C0001617 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0205163 (UMLS CUI [1,4])
C0521116 (UMLS CUI [1,5])
Hepatitis b virus surface antigen positive | HIV test positive
Item
infection with hepatitis b virus (hbv) or hiv at screening
boolean
C0019168 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C1321876 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
Current, uncontrolled ascites | Variceal hemorrhage | Hepatic encephalopathy | Hepatorenal syndrome | Hepatopulmonary syndrome | Other signs of decompensated cirrhosis
Item
current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
boolean
C0003962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0333106 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0019151 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0019212 (UMLS CUI [4])
C0600452 (UMLS CUI [5])
C1394798 (UMLS CUI [6,1])
C0521116 (UMLS CUI [6,2])
C0037088 (UMLS CUI [6,3])
C0205394 (UMLS CUI [6,4])
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