ID

40909

Descrição

Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders; ODM derived from: https://clinicaltrials.gov/show/NCT01273064

Link

https://clinicaltrials.gov/show/NCT01273064

Palavras-chave

Versões (1)
  1. 03/06/2020 03/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01273064

Inglês

Eligibility Hepatitis C NCT01273064

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Descrição

Adult | Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
2. hcv genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, soc) defined as:
Descrição

Hepatitis C Genotype | Therapy non-responder PEGINTERFERON/RIBAVIRIN

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0919875
UMLS CUI [2,2]
C1875630
failure to achieve an early virologic response (< 2 log decline in hcv-rna by week 12), or
Descrição

Virologic Response Early failed | Decrease;Hepatitis C virus RNA Week Number

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4053862
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0547047
UMLS CUI [2,2]
C0369335
UMLS CUI [2,3]
C0439230
UMLS CUI [2,4]
C0237753
if week 12 hcv-rna was not obtained, post week 12 hcv-rna response was < 2 log decline
Descrição

Week Number Hepatitis C virus RNA failed | Hepatitis C virus RNA Response | Status post Week Number

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0369335
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C4053862
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0439230
UMLS CUI [3,3]
C0237753
3. screening hcv-rna viral load of > 5.0 log (i.e., >100,000 iu/ml)
Descrição

Hepatitis C virus RNA assay

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1272251
4. alpha-fetoprotein (afp) less than or equal to 100 ng/ml
Descrição

Alpha-fetoprotein measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201539
5. hemoglobin greater than or equal to 12 g/dl for women and greater than or equal to 13 g/dl for men, hemoglobin a1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10^9/l, and white blood cell count greater than or equal to 1.5 x 10^9/l
Descrição

Hemoglobin measurement | Gender | Hemoglobin A1c measurement | Platelet Count measurement | White Blood Cell Count procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0474680
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0023508
6. thyroid stimulating hormone (tsh) within normal limits
Descrição

Serum TSH level normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0580433
7. in the opinion of the principal investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
Descrição

PEGINTERFERON/RIBAVIRIN Dose Percentage | Dose Size Percentage | Duration of treatment Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0439165
UMLS CUI [3,1]
C0444921
UMLS CUI [3,2]
C0439165
8. willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the study.
Descrição

Females & males of reproductive potential Contraceptive methods Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. < 2 log decline in hcv-rna at week 12 but > 2 log decline at any time from week 12 to week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
Descrição

Decrease Hepatitis C virus RNA Week Number | Decrease Hepatitis C virus RNA Timepoint

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0547047
UMLS CUI [1,2]
C0369335
UMLS CUI [1,3]
C0439230
UMLS CUI [1,4]
C0237753
UMLS CUI [2,1]
C0547047
UMLS CUI [2,2]
C0369335
UMLS CUI [2,3]
C2348792
2. decompensated or severe liver disease defined by one or more of the following criteria:
Descrição

End Stage Liver Disease | Liver disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
prothrombin time 4 seconds > control or inr (international normalized ratio) > 1.2
Descrição

Prothrombin time assay | INR

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
total bilirubin ≥ 1.5 mg/dl or direct bilirubin ≥ 1 mg/dl
Descrição

Serum total bilirubin measurement | Bilirubin, direct measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201916
serum albumin below normal limits
Descrição

Serum albumin level decreased below normal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3665623
aspartate aminotransferase (ast) or alanine aminotransferase (alt)> 5 x upper limit of normal (uln) at screening
Descrição

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
presence of ascites
Descrição

Ascites

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003962
3. hepatic encephalopathy
Descrição

Hepatic Encephalopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019151
4. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
Descrição

Liver carcinoma Clinical examination | Suspicion Liver carcinoma Clinical examination | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C1456356
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C2239176
UMLS CUI [2,3]
C1456356
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0242114
UMLS CUI [4,2]
C2239176
UMLS CUI [4,3]
C0041618
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0079595
UMLS CUI [6,1]
C0242114
UMLS CUI [6,2]
C2239176
UMLS CUI [6,3]
C0079595
5. clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
Descrição

|

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0015392
UMLS CUI [1,3]
C2826293
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0271053
UMLS CUI [4]
C0029132
UMLS CUI [5]
C0035317
UMLS CUI [6]
C4316870
6. known history or presence of human immunodeficiency virus (hiv) infection
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
7. co-infection with hepatitis b virus (hbv)
Descrição

HBV coinfection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2242656
8. if female: pregnant, lactating, or positive serum or urine pregnancy test
Descrição

Pregnancy | Breast Feeding | Serum pregnancy test positive | Urine pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430063
UMLS CUI [4]
C0430059
9. male partners of women who are currently pregnant
Descrição

Partner Gender Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0079399
UMLS CUI [1,3]
C0032961
10. renal impairment (creatinine > 1.2 x uln), serum creatinine clearance < 50 ml/min, or hepatorenal syndrome with ascites
Descrição

Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Hepatorenal Syndrome with Ascites

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C0019212
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C0003962
11. hospitalization for liver disease within 60 days of screening
Descrição

Hospitalization Due to Liver disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0023895
12. history of alcohol abuse (> 50 g per day) within the past year
Descrição

Alcohol abuse | Alcohol consumption U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0456683
13. history of severe psychiatric disease, especially depression, characterized by:
Descrição

Mental Disorders, Severe | Depressive disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0011581
suicide attempt
Descrição

Suicide attempt

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038663
hospitalization for psychiatric disease
Descrição

Hospitalization Due to Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004936
period of disability as a result of psychiatric disease
Descrição

Disability Due to Mental disorder

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0004936
14. prior exposure to cts-1027
Descrição

Exposure to CTS-1027

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C4534678
15. patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin
Descrição

Therapy non-responder | Therapy Except PEGINTERFERON/RIBAVIRIN

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1875630
16. history or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose corrected q-t interval (qtc) of > 450 milliseconds
Descrição

Cardiac Arrhythmia | Prolonged QTc interval

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C1560305
17. history of or current autoimmune disease
Descrição

Autoimmune Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004364
18. diagnosis of or symptoms suggestive of fibromyalgia
Descrição

Fibromyalgia | Symptoms Suggestive of Fibromyalgia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0016053
19. currently on liver transplantation waiting list or recipient of any organ transplant
Descrição

Patient on waiting list Transplantation of liver | Recipient Organ transplant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0023911
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0524930
20. other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Descrição

Comorbidity Limiting Life Expectancy | Condition Limiting Life Expectancy | Congestive heart failure Moderate | Congestive heart failure Severe | Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Malignant Neoplasm Treated | Exception Malignant Neoplasm In complete remission

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0023671
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0006826
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0007117
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1273390
UMLS CUI [7,3]
C0553723
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0006826
UMLS CUI [8,3]
C1522326
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0006826
UMLS CUI [9,3]
C0677874
21. exposure to any other investigational treatment for any aspect of disease associated with hcv during the past 6 months
Descrição

Exposure to Investigational Therapy | Disease Associated with Hepatitis C virus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0949266
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0220847
22. exposure to any investigational drug or device within 30 days of dosing, or scheduled receipt of another investigational drug or device during the course of this study.
Descrição

Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2346570
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C2346570
UMLS CUI [4,2]
C0205539
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Eligibility Hepatitis C NCT01273064

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Informed Consent | Protocol Compliance
Item
1. male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
boolean
C0001675 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Hepatitis C Genotype | Therapy non-responder PEGINTERFERON/RIBAVIRIN
Item
2. hcv genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, soc) defined as:
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0919875 (UMLS CUI [2,1])
C1875630 (UMLS CUI [2,2])
Virologic Response Early failed | Decrease;Hepatitis C virus RNA Week Number
Item
failure to achieve an early virologic response (< 2 log decline in hcv-rna by week 12), or
boolean
C4053862 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0547047 (UMLS CUI [2,1])
C0369335 (UMLS CUI [2,2])
C0439230 (UMLS CUI [2,3])
C0237753 (UMLS CUI [2,4])
Week Number Hepatitis C virus RNA failed | Hepatitis C virus RNA Response | Status post Week Number
Item
if week 12 hcv-rna was not obtained, post week 12 hcv-rna response was < 2 log decline
boolean
C0439230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0369335 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0369335 (UMLS CUI [2,1])
C4053862 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0439230 (UMLS CUI [3,2])
C0237753 (UMLS CUI [3,3])
Hepatitis C virus RNA assay
Item
3. screening hcv-rna viral load of > 5.0 log (i.e., >100,000 iu/ml)
boolean
C1272251 (UMLS CUI [1])
Alpha-fetoprotein measurement
Item
4. alpha-fetoprotein (afp) less than or equal to 100 ng/ml
boolean
C0201539 (UMLS CUI [1])
Hemoglobin measurement | Gender | Hemoglobin A1c measurement | Platelet Count measurement | White Blood Cell Count procedure
Item
5. hemoglobin greater than or equal to 12 g/dl for women and greater than or equal to 13 g/dl for men, hemoglobin a1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10^9/l, and white blood cell count greater than or equal to 1.5 x 10^9/l
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
Serum TSH level normal
Item
6. thyroid stimulating hormone (tsh) within normal limits
boolean
C0580433 (UMLS CUI [1])
PEGINTERFERON/RIBAVIRIN Dose Percentage | Dose Size Percentage | Duration of treatment Percentage
Item
7. in the opinion of the principal investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
boolean
C1875630 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0444921 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Females & males of reproductive potential Contraceptive methods Quantity
Item
8. willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Decrease Hepatitis C virus RNA Week Number | Decrease Hepatitis C virus RNA Timepoint
Item
1. < 2 log decline in hcv-rna at week 12 but > 2 log decline at any time from week 12 to week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
boolean
C0547047 (UMLS CUI [1,1])
C0369335 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0547047 (UMLS CUI [2,1])
C0369335 (UMLS CUI [2,2])
C2348792 (UMLS CUI [2,3])
End Stage Liver Disease | Liver disease Severe
Item
2. decompensated or severe liver disease defined by one or more of the following criteria:
boolean
C0745744 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Prothrombin time assay | INR
Item
prothrombin time 4 seconds > control or inr (international normalized ratio) > 1.2
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Serum total bilirubin measurement | Bilirubin, direct measurement
Item
total bilirubin ≥ 1.5 mg/dl or direct bilirubin ≥ 1 mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
Serum albumin level decreased below normal
Item
serum albumin below normal limits
boolean
C3665623 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt)> 5 x upper limit of normal (uln) at screening
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Ascites
Item
presence of ascites
boolean
C0003962 (UMLS CUI [1])
Hepatic Encephalopathy
Item
3. hepatic encephalopathy
boolean
C0019151 (UMLS CUI [1])
Liver carcinoma Clinical examination | Suspicion Liver carcinoma Clinical examination | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique
Item
4. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
boolean
C2239176 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
C2239176 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C2239176 (UMLS CUI [5,1])
C0079595 (UMLS CUI [5,2])
C0242114 (UMLS CUI [6,1])
C2239176 (UMLS CUI [6,2])
C0079595 (UMLS CUI [6,3])
Signs and Symptoms Eye Clinical Significance | Retinal Disease | Cotton wool spots | Disorder of the optic nerve | Retinal Hemorrhage | Abnormality of the eye
Item
5. clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
boolean
C0037088 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0035309 (UMLS CUI [2])
C0271053 (UMLS CUI [3])
C0029132 (UMLS CUI [4])
C0035317 (UMLS CUI [5])
C4316870 (UMLS CUI [6])
HIV Infection
Item
6. known history or presence of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
HBV coinfection
Item
7. co-infection with hepatitis b virus (hbv)
boolean
C2242656 (UMLS CUI [1])
Pregnancy | Breast Feeding | Serum pregnancy test positive | Urine pregnancy test positive
Item
8. if female: pregnant, lactating, or positive serum or urine pregnancy test
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430063 (UMLS CUI [3])
C0430059 (UMLS CUI [4])
Partner Gender Pregnancy
Item
9. male partners of women who are currently pregnant
boolean
C0682323 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Hepatorenal Syndrome with Ascites
Item
10. renal impairment (creatinine > 1.2 x uln), serum creatinine clearance < 50 ml/min, or hepatorenal syndrome with ascites
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0019212 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C0003962 (UMLS CUI [4,3])
Hospitalization Due to Liver disease
Item
11. hospitalization for liver disease within 60 days of screening
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
Alcohol abuse | Alcohol consumption U/day
Item
12. history of alcohol abuse (> 50 g per day) within the past year
boolean
C0085762 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Mental Disorders, Severe | Depressive disorder
Item
13. history of severe psychiatric disease, especially depression, characterized by:
boolean
C4046029 (UMLS CUI [1])
C0011581 (UMLS CUI [2])
Suicide attempt
Item
suicide attempt
boolean
C0038663 (UMLS CUI [1])
Hospitalization Due to Mental disorders
Item
hospitalization for psychiatric disease
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Disability Due to Mental disorder
Item
period of disability as a result of psychiatric disease
boolean
C0231170 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Exposure to CTS-1027
Item
14. prior exposure to cts-1027
boolean
C0332157 (UMLS CUI [1,1])
C4534678 (UMLS CUI [1,2])
Therapy non-responder | Therapy Except PEGINTERFERON/RIBAVIRIN
Item
15. patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin
boolean
C0919875 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1875630 (UMLS CUI [2,3])
Cardiac Arrhythmia | Prolonged QTc interval
Item
16. history or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose corrected q-t interval (qtc) of > 450 milliseconds
boolean
C0003811 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
Autoimmune Disease
Item
17. history of or current autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Fibromyalgia | Symptoms Suggestive of Fibromyalgia
Item
18. diagnosis of or symptoms suggestive of fibromyalgia
boolean
C0016053 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0016053 (UMLS CUI [2,3])
Patient on waiting list Transplantation of liver | Recipient Organ transplant
Item
19. currently on liver transplantation waiting list or recipient of any organ transplant
boolean
C0422768 (UMLS CUI [1,1])
C0023911 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0524930 (UMLS CUI [2,2])
Comorbidity Limiting Life Expectancy | Condition Limiting Life Expectancy | Congestive heart failure Moderate | Congestive heart failure Severe | Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Malignant Neoplasm Treated | Exception Malignant Neoplasm In complete remission
Item
20. other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0023671 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0007117 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0553723 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0006826 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0006826 (UMLS CUI [9,2])
C0677874 (UMLS CUI [9,3])
Exposure to Investigational Therapy | Disease Associated with Hepatitis C virus
Item
21. exposure to any other investigational treatment for any aspect of disease associated with hcv during the past 6 months
boolean
C0332157 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0220847 (UMLS CUI [2,3])
Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled
Item
22. exposure to any investigational drug or device within 30 days of dosing, or scheduled receipt of another investigational drug or device during the course of this study.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
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