ID

36032

Description

SMV + SOF With/Without RBV for IFN-II Patients With CHC; ODM derived from: https://clinicaltrials.gov/show/NCT02214420

Link

https://clinicaltrials.gov/show/NCT02214420

Keywords

Versions (1)
  1. 4/10/19 4/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT02214420

English

Eligibility Hepatitis C NCT02214420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. targeted at least 20% enrollment of patients with cirrhosis
Description

Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
2. adults >/= age 18 years.
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
3. active infection with hcv genotype 1
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1285573
4. must have health insurance that covers therapy with sof+rbv
Description

Health Insurance | sofosbuvir | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0021682
UMLS CUI [2]
C2976303
UMLS CUI [3]
C0035525
5. female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
6. patients must be either ifn-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the pi; or,
Description

Patients Ineligible Interferon | Etiology Mental disorders | Etiology Autoimmune Diseases | Etiology Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C3652465
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0004936
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0004364
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0027765
7. ifn-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the pi.
Description

Intolerance to Interferon | Etiology Influenza-like symptoms | Etiology Psychiatric problem | Etiology Cytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C3652465
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0392171
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1306597
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0010828
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of hiv co-infection
Description

HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C4062778
2. presence of hcc
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
3. prior organ transplantation
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
4. any history of hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
5. patients taking any of the following medications:
Description

Intake Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0013227
anticonvulsants- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin.
Description

Anticonvulsants | Carbamazepine | oxcarbazepine | Phenobarbital | Phenytoin

Data type

boolean

Alias
UMLS CUI [1]
C0003286
UMLS CUI [2]
C0006949
UMLS CUI [3]
C0069751
UMLS CUI [4]
C0031412
UMLS CUI [5]
C0031507
anti-infectives-erythromycin, clarithromycin, or telithromycin.
Description

Anti-Infective Agents | Erythromycin | Clarithromycin | telithromycin

Data type

boolean

Alias
UMLS CUI [1]
C0003204
UMLS CUI [2]
C0014806
UMLS CUI [3]
C0055856
UMLS CUI [4]
C0907410
antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
Description

Antifungal Agents | Itraconazole Systemic | Ketoconazole | posaconazole | Fluconazole | voriconazole

Data type

boolean

Alias
UMLS CUI [1]
C0003308
UMLS CUI [2,1]
C0064113
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0936148
UMLS CUI [5]
C0016277
UMLS CUI [6]
C0393080
antimycobacterials- rifampin, rifabutin or rifapentine.
Description

Antimycobacterial agent | Rifampin | Rifabutin | rifapentine

Data type

boolean

Alias
UMLS CUI [1]
C0360390
UMLS CUI [2]
C0035608
UMLS CUI [3]
C0140575
UMLS CUI [4]
C0073372
corticosteroids- systemic dexamethasone.
Description

Adrenal Cortex Hormones | Dexamethasone Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C0205373
propulsives- cisapride.
Description

PROPULSIVES | Cisapride

Data type

boolean

Alias
UMLS CUI [1]
C3653283
UMLS CUI [2]
C0072916
herbals- milk thistle or st. john's wart.
Description

Herbal Drugs | Milk thistle extract | Hypericum perforatum

Data type

boolean

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C0937640
UMLS CUI [3]
C0936242
6. patients that have been exposed to direct acting anti-viral agents
Description

Exposure to DIRECT ACTING ANTIVIRALS

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C3653501
7. patients with severe renal impairment (estimated glomerular filtration rate (egfr) <50 ml/min/1.73m2) or with end stage renal disease (esrd).
Description

Renal Insufficiency | Estimated Glomerular Filtration Rate | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
UMLS CUI [3]
C0022661
8. patients with platelet count <50 x109/l, hemoglobin <10 g/dl, or neutrophils <0.5 x109/l.
Description

Platelet Count measurement | Hemoglobin measurement | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0200633
9. women who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
10. men whose partners are pregnant or plan on becoming pregnant.
Description

Gender Partner Pregnancy | Gender Partner Planned Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0032992
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Similar models

Eligibility Hepatitis C NCT02214420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver Cirrhosis
Item
1. targeted at least 20% enrollment of patients with cirrhosis
boolean
C0023890 (UMLS CUI [1])
Adult | Age
Item
2. adults >/= age 18 years.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C Genotype
Item
3. active infection with hcv genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
Health Insurance | sofosbuvir | Ribavirin
Item
4. must have health insurance that covers therapy with sof+rbv
boolean
C0021682 (UMLS CUI [1])
C2976303 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Pregnancy Tests
Item
5. female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Patients Ineligible Interferon | Etiology Mental disorders | Etiology Autoimmune Diseases | Etiology Nervous system disorder
Item
6. patients must be either ifn-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the pi; or,
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C3652465 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0004364 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0027765 (UMLS CUI [4,2])
Intolerance to Interferon | Etiology Influenza-like symptoms | Etiology Psychiatric problem | Etiology Cytopenia
Item
7. ifn-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the pi.
boolean
C1744706 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0392171 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1306597 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0010828 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
HIV coinfection
Item
1. presence of hiv co-infection
boolean
C4062778 (UMLS CUI [1])
Liver carcinoma
Item
2. presence of hcc
boolean
C2239176 (UMLS CUI [1])
Organ Transplantation
Item
3. prior organ transplantation
boolean
C0029216 (UMLS CUI [1])
Hepatic decompensation
Item
4. any history of hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Intake Pharmaceutical Preparations
Item
5. patients taking any of the following medications:
boolean
C1512806 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Anticonvulsants | Carbamazepine | oxcarbazepine | Phenobarbital | Phenytoin
Item
anticonvulsants- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin.
boolean
C0003286 (UMLS CUI [1])
C0006949 (UMLS CUI [2])
C0069751 (UMLS CUI [3])
C0031412 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
Anti-Infective Agents | Erythromycin | Clarithromycin | telithromycin
Item
anti-infectives-erythromycin, clarithromycin, or telithromycin.
boolean
C0003204 (UMLS CUI [1])
C0014806 (UMLS CUI [2])
C0055856 (UMLS CUI [3])
C0907410 (UMLS CUI [4])
Antifungal Agents | Itraconazole Systemic | Ketoconazole | posaconazole | Fluconazole | voriconazole
Item
antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
boolean
C0003308 (UMLS CUI [1])
C0064113 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0936148 (UMLS CUI [4])
C0016277 (UMLS CUI [5])
C0393080 (UMLS CUI [6])
Antimycobacterial agent | Rifampin | Rifabutin | rifapentine
Item
antimycobacterials- rifampin, rifabutin or rifapentine.
boolean
C0360390 (UMLS CUI [1])
C0035608 (UMLS CUI [2])
C0140575 (UMLS CUI [3])
C0073372 (UMLS CUI [4])
Adrenal Cortex Hormones | Dexamethasone Systemic
Item
corticosteroids- systemic dexamethasone.
boolean
C0001617 (UMLS CUI [1])
C0011777 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
PROPULSIVES | Cisapride
Item
propulsives- cisapride.
boolean
C3653283 (UMLS CUI [1])
C0072916 (UMLS CUI [2])
Herbal Drugs | Milk thistle extract | Hypericum perforatum
Item
herbals- milk thistle or st. john's wart.
boolean
C1360419 (UMLS CUI [1])
C0937640 (UMLS CUI [2])
C0936242 (UMLS CUI [3])
Exposure to DIRECT ACTING ANTIVIRALS
Item
6. patients that have been exposed to direct acting anti-viral agents
boolean
C0332157 (UMLS CUI [1,1])
C3653501 (UMLS CUI [1,2])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Kidney Failure, Chronic
Item
7. patients with severe renal impairment (estimated glomerular filtration rate (egfr) <50 ml/min/1.73m2) or with end stage renal disease (esrd).
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
Platelet Count measurement | Hemoglobin measurement | Neutrophil count
Item
8. patients with platelet count <50 x109/l, hemoglobin <10 g/dl, or neutrophils <0.5 x109/l.
boolean
C0032181 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Pregnancy
Item
9. women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Gender Partner Pregnancy | Gender Partner Planned Pregnancy
Item
10. men whose partners are pregnant or plan on becoming pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0032992 (UMLS CUI [2,3])
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