ID

39577

Beschreibung

Boceprevir in End Stage Renal Disease (ESRD); ODM derived from: https://clinicaltrials.gov/show/NCT02112630

Link

https://clinicaltrials.gov/show/NCT02112630

Stichworte

Versionen (1)
  1. 31.01.20 31.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

31. Januar 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C Infection NCT02112630

Englisch

Eligibility Hepatitis C Infection NCT02112630

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult (ages 18-75)
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
2. hepatitis c virus ribonucleic acid (hcv rna) 1000 iu/ml or greater
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
3. hepatitis c virus (hcv) genotype 1
Beschreibung

Hepatitis C virus genotype determination

Datentyp

boolean

Alias
UMLS CUI [1]
C1533728
4. end stage renal disease on hemodialysis
Beschreibung

Kidney Failure, Chronic | Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
5. females of child bearing potential must be using an adequate method of contraception throughout the study and must have a negative pregnancy test prior to the start of treatment.
Beschreibung

Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. intolerance to peg-ifn or ribavirin with prior treatment course.
Beschreibung

Intolerance to PEGINTERFERON | Intolerance to Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0035525
2. prior treatment with protease inhibitor (telaprevir or boceprevir) or experimental protease inhibitor
Beschreibung

Protease Inhibitors | telaprevir | boceprevir | Protease Inhibitors Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0033607
UMLS CUI [2]
C1876229
UMLS CUI [3]
C1738934
UMLS CUI [4,1]
C0033607
UMLS CUI [4,2]
C1517586
3. significant cytopenias:
Beschreibung

Cytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0010828
1. absolute neutrophil count (anc) < 1000/mm3, or
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
2. hemoglobin (hgb) <10.5 g/dl, or
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
3. platelet count < 50,000/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
4. significant laboratory abnormalities
Beschreibung

Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
1. direct bilirubin > 1.5 x upper limit of normal (uln)
Beschreibung

Direct bilirubin increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0740434
2. total bilirubin > 1.6 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
3. prothrombin time (pt)/partial thromboplastin time (ptt) > 10% above laboratory reference range
Beschreibung

Prothrombin time increased | Partial thromboplastin time increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2]
C0240671
4. thyroid stimulating hormone (tsh) > 1.2 x uln or < 0.8 x lower limit of normal (lln)
Beschreibung

Raised TSH level | Decreased thyroid stimulating hormone level

Datentyp

boolean

Alias
UMLS CUI [1]
C0586553
UMLS CUI [2]
C1295607
5. uncontrolled depression or psychiatric disease
Beschreibung

Depressive disorder Uncontrolled | Mental disorder Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
6. uncontrolled cardiopulmonary or cardiovascular disease
Beschreibung

Cor pulmonale Uncontrolled | Cardiovascular Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034072
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
7. autoimmune diseases except for treated thyroid disease
Beschreibung

Autoimmune Diseases | Exception Thyroid Disease Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0040128
UMLS CUI [2,3]
C1522326
8. active substance abuse within 6 months of initiation of treatment
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
9. recent (within 4 weeks) episode of infection requiring systemic antibiotics
Beschreibung

Episode of Communicable Disease Recent | Requirement Antibiotics for systemic use

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0009450
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3540704
10. any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation
Beschreibung

Medical condition Exacerbation Due to Therapy | Medical condition Limiting Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C4086268
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C2348568
11. any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study
Beschreibung

Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653708
UMLS CUI [1,4]
C0205191
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
12. human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
Beschreibung

HIV coinfection | HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C2242656
13. hepatocellular carcinoma (hcc) (patients with hcc who are listed for liver transplantation may be included.)
Beschreibung

Liver carcinoma | Exception Patient on waiting list Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0422768
UMLS CUI [2,3]
C0023911
14. other significant chronic liver disease diagnosis
Beschreibung

Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
15. evidence of decompensated liver disease
Beschreibung

Decompensated liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4075847
16. solid organ transplant recipient (patients who have a history of renal transplant, and have experienced kidney graft loss, and are not on immunosuppression may be included.)
Beschreibung

Solid organ transplant Recipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1709854
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Ähnliche Modelle

Eligibility Hepatitis C Infection NCT02112630

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
1. adult (ages 18-75)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C virus RNA assay
Item
2. hepatitis c virus ribonucleic acid (hcv rna) 1000 iu/ml or greater
boolean
C1272251 (UMLS CUI [1])
Hepatitis C virus genotype determination
Item
3. hepatitis c virus (hcv) genotype 1
boolean
C1533728 (UMLS CUI [1])
Kidney Failure, Chronic | Hemodialysis
Item
4. end stage renal disease on hemodialysis
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
5. females of child bearing potential must be using an adequate method of contraception throughout the study and must have a negative pregnancy test prior to the start of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Intolerance to PEGINTERFERON | Intolerance to Ribavirin
Item
1. intolerance to peg-ifn or ribavirin with prior treatment course.
boolean
C1744706 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Protease Inhibitors | telaprevir | boceprevir | Protease Inhibitors Investigational
Item
2. prior treatment with protease inhibitor (telaprevir or boceprevir) or experimental protease inhibitor
boolean
C0033607 (UMLS CUI [1])
C1876229 (UMLS CUI [2])
C1738934 (UMLS CUI [3])
C0033607 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Cytopenia
Item
3. significant cytopenias:
boolean
C0010828 (UMLS CUI [1])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) < 1000/mm3, or
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
2. hemoglobin (hgb) <10.5 g/dl, or
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelet count < 50,000/mm3
boolean
C0032181 (UMLS CUI [1])
Laboratory test result abnormal
Item
4. significant laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Direct bilirubin increased
Item
1. direct bilirubin > 1.5 x upper limit of normal (uln)
boolean
C0740434 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
2. total bilirubin > 1.6 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])
Prothrombin time increased | Partial thromboplastin time increased
Item
3. prothrombin time (pt)/partial thromboplastin time (ptt) > 10% above laboratory reference range
boolean
C0151872 (UMLS CUI [1])
C0240671 (UMLS CUI [2])
Raised TSH level | Decreased thyroid stimulating hormone level
Item
4. thyroid stimulating hormone (tsh) > 1.2 x uln or < 0.8 x lower limit of normal (lln)
boolean
C0586553 (UMLS CUI [1])
C1295607 (UMLS CUI [2])
Depressive disorder Uncontrolled | Mental disorder Uncontrolled
Item
5. uncontrolled depression or psychiatric disease
boolean
C0011581 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Cor pulmonale Uncontrolled | Cardiovascular Disease Uncontrolled
Item
6. uncontrolled cardiopulmonary or cardiovascular disease
boolean
C0034072 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Autoimmune Diseases | Exception Thyroid Disease Treated
Item
7. autoimmune diseases except for treated thyroid disease
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0040128 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Substance Use Disorder
Item
8. active substance abuse within 6 months of initiation of treatment
boolean
C0038586 (UMLS CUI [1])
Episode of Communicable Disease Recent | Requirement Antibiotics for systemic use
Item
9. recent (within 4 weeks) episode of infection requiring systemic antibiotics
boolean
C0332189 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C3540704 (UMLS CUI [2,2])
Medical condition Exacerbation Due to Therapy | Medical condition Limiting Study Subject Participation Status
Item
10. any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation
boolean
C3843040 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Medical condition Requirement CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Medical condition Requirement Immunosuppressive Agents
Item
11. any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653708 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
12. human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Liver carcinoma | Exception Patient on waiting list Transplantation of liver
Item
13. hepatocellular carcinoma (hcc) (patients with hcc who are listed for liver transplantation may be included.)
boolean
C2239176 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0422768 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
Chronic liver disease
Item
14. other significant chronic liver disease diagnosis
boolean
C0341439 (UMLS CUI [1])
Decompensated liver disease
Item
15. evidence of decompensated liver disease
boolean
C4075847 (UMLS CUI [1])
Solid organ transplant Recipient
Item
16. solid organ transplant recipient (patients who have a history of renal transplant, and have experienced kidney graft loss, and are not on immunosuppression may be included.)
boolean
C0730400 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
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