ID

43567

Beschrijving

Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00203606

Link

https://clinicaltrials.gov/show/NCT00203606

Trefwoorden

Versies (3)
  1. 21-09-16 21-09-16 -
  2. 21-09-16 21-09-16 -
  3. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis c NCT00203606

Engels

Eligibility Hepatitis c NCT00203606

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women age 18 to 75 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. chronic hepatitis c infection based on a history of positive anti-hcv antibody and/or hcv rna at least 6 months prior to study entry.
Beschrijving

Hepatitis C, Chronic | Hepatitis C antibody positive | HCV viral load Positive

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C0281863
UMLS CUI [3,1]
C1868902
UMLS CUI [3,2]
C1514241
3. positive hcv-rna by roche amplicor hcv test at screening
Beschrijving

HCV viral load Positive | Hepatitis C virus test

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C2363789
4. serum alt > 1.5 times upper limit of normal
Beschrijving

Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
5. active or past use of injection drugs or crack cocaine by self-report. active use is defined as injection drug use at least 1/month and within 3 months of the date of randomization. past use is defined as no injection drug use or crack cocaine use within the past 5 years.
Beschrijving

Injecting drug user | Crack Cocaine Use of

Datatype

boolean

Alias
UMLS CUI [1]
C0556025
UMLS CUI [2,1]
C0085163
UMLS CUI [2,2]
C1524063
6. compensated liver disease
Beschrijving

Compensated liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C3839044
7. negative urine or blood pregnancy tests (for women of childbearing potential) documented within 24-hours prior to first dose of study drug.
Beschrijving

Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0850355
UMLS CUI [2,3]
C1513916
8. all fertile males and females must use effective contraception during treatment and during the 6 months after treatment end if sexually active (this will be provided free of charge to active idus).
Beschrijving

Fertility Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of variceal bleeding within the last two years.
Beschrijving

Ascites Evidence Clinical Requirement Diuretic therapy | Therapeutic procedure Hepatic Encephalopathy | Bleeding varices

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C1514873
UMLS CUI [1,5]
C0948575
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0019151
UMLS CUI [3]
C0333106
2. platelet count < 60,000/mm3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
3. serum alt level > 10 times upper limit of normal
Beschrijving

Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
4. serum creatinine level > 1.5 times the upper limit of normal (deleted february 27, 2007, protocol amendment #4, ethics approval march 28, 2007)
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
5. hematology outside of specified limits: neutrophil count < 1000/mm3, hemoglobin < 10 g/l in males and < 9 g/l in females
Beschrijving

Hematology | Absolute neutrophil count | Hemoglobin | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0474523
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0079399
7. unstable or uncontrolled thyroid disease 8. treatment with interferon- and/or ribavirin within the previous 12 months 9. presence of clinically significant cryoglobulinemia vasculitis (e.g. skin rash, arthritis, or renal insufficiency due to cryoglobulinemia) 10. presence or history of autoimmune hepatitis, alpha-1-anti-trypsin deficiency, genetic hemochromatosis, wilson disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis.
Beschrijving

Thyroid Diseases Unstable | Thyroid Diseases Uncontrolled | Interferon therapy | Ribavirin | Vasculitis Clinical Significance Due to Cryoglobulinemia | Exanthema Due to Cryoglobulinemia | Arthritis Due to Cryoglobulinemia | Renal Insufficiency Due to Cryoglobulinemia | Hepatitis, Autoimmune | alpha 1-Antitrypsin Deficiency | Hereditary hemochromatosis | Hepatolenticular Degeneration | Drug-induced disorder of liver | Liver diseases Due to Toxin | Alcoholic Liver Diseases | Primary biliary cirrhosis | Cholangitis, Sclerosing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0279030
UMLS CUI [4]
C0035525
UMLS CUI [5,1]
C0042384
UMLS CUI [5,2]
C2826293
UMLS CUI [5,3]
C0678226
UMLS CUI [5,4]
C0010403
UMLS CUI [6,1]
C0015230
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C0010403
UMLS CUI [7,1]
C0003864
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0010403
UMLS CUI [8,1]
C1565489
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0010403
UMLS CUI [9]
C0241910
UMLS CUI [10]
C0221757
UMLS CUI [11]
C0392514
UMLS CUI [12]
C0019202
UMLS CUI [13]
C0860207
UMLS CUI [14,1]
C0023895
UMLS CUI [14,2]
C0678226
UMLS CUI [14,3]
C0040549
UMLS CUI [15]
C0023896
UMLS CUI [16]
C0008312
UMLS CUI [17]
C0008313
11. chronic hepatitis b infection or positive hbsag at screening 12. known history of hiv infection or positive hiv antibody test by western blot.
Beschrijving

Hepatitis B, Chronic | Hepatitis B surface antigen positive | HIV Infections | HIV TEST WESTERN BLOT POSITIVE

Datatype

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0745009
13. a disease known to cause significant alteration in immunologic function, including hematological malignancy or autoimmune disorder.
Beschrijving

Disease Causing Immune System Processes Alteration Significant | Hematologic Neoplasms | Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1817756
UMLS CUI [1,4]
C1515926
UMLS CUI [1,5]
C0750502
UMLS CUI [2]
C0376545
UMLS CUI [3]
C0004364
14. concurrent therapy with immunosuppressive drugs or cytotoxic agents, such as prednisone, cyclosporine, azathioprine or chemotherapeutic agents.
Beschrijving

Immunosuppressive Agents | Cytotoxic agent | Prednisone | Cyclosporine | Azathioprine | Antineoplastic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0304497
UMLS CUI [3]
C0032952
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0003392
15. history of unstable or deteriorating cardiac, pulmonary or renal disease. 16. preexisting (within last two years) or active psychiatric condition including severe untreated depression, major psychoses, suicidal ideation or suicidal attempts.
Beschrijving

Heart Diseases Unstable | Lung diseases Unstable | Kidney Diseases Unstable | Heart Diseases Worsening | Lung diseases Worsening | Kidney Diseases Worsening | Mental disorders | Severe depression | Psychotic Disorders Major | Feeling suicidal | Suicide attempt

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0332271
UMLS CUI [5,1]
C0024115
UMLS CUI [5,2]
C0332271
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0332271
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0588008
UMLS CUI [9,1]
C0033975
UMLS CUI [9,2]
C0205164
UMLS CUI [10]
C0424000
UMLS CUI [11]
C0038663
17. severe or poorly controlled diabetes mellitus 18. any serious or chronic disease that may affect the assessment of safety or efficacy parameters.
Beschrijving

Diabetes Mellitus Severe | Diabetes mellitus poor control | Disease Serious Affecting safety assessment | Disease Serious Affecting Evaluation | Chronic disease Affecting safety assessment | Chronic disease Affecting Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0860161
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C1161149
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0220825
UMLS CUI [5,1]
C0008679
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1161149
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0220825
19. patients who have had a liver transplant 20. patients infected with hcv genotypes 4, 5 or 6 (< 1% of infected current/past idus)
Beschrijving

Transplantation of liver | Hepatitis C virus genotype | Injecting drug user

Datatype

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C1148363
UMLS CUI [3]
C0556025
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Similar models

Eligibility Hepatitis c NCT00203606

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men or women age 18 to 75 years.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C antibody positive | HCV viral load Positive
Item
2. chronic hepatitis c infection based on a history of positive anti-hcv antibody and/or hcv rna at least 6 months prior to study entry.
boolean
C0524910 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C1868902 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
HCV viral load Positive | Hepatitis C virus test
Item
3. positive hcv-rna by roche amplicor hcv test at screening
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C2363789 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
4. serum alt > 1.5 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Injecting drug user | Crack Cocaine Use of
Item
5. active or past use of injection drugs or crack cocaine by self-report. active use is defined as injection drug use at least 1/month and within 3 months of the date of randomization. past use is defined as no injection drug use or crack cocaine use within the past 5 years.
boolean
C0556025 (UMLS CUI [1])
C0085163 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
Compensated liver disease
Item
6. compensated liver disease
boolean
C3839044 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential pregnancy blood test Negative
Item
7. negative urine or blood pregnancy tests (for women of childbearing potential) documented within 24-hours prior to first dose of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0850355 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Fertility Sexually active Contraceptive methods
Item
8. all fertile males and females must use effective contraception during treatment and during the 6 months after treatment end if sexually active (this will be provided free of charge to active idus).
boolean
C0015895 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Ascites Evidence Clinical Requirement Diuretic therapy | Therapeutic procedure Hepatic Encephalopathy | Bleeding varices
Item
1. presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of variceal bleeding within the last two years.
boolean
C0003962 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0948575 (UMLS CUI [1,5])
C0087111 (UMLS CUI [2,1])
C0019151 (UMLS CUI [2,2])
C0333106 (UMLS CUI [3])
Platelet Count measurement
Item
2. platelet count < 60,000/mm3
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
3. serum alt level > 10 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Creatinine measurement, serum
Item
4. serum creatinine level > 1.5 times the upper limit of normal (deleted february 27, 2007, protocol amendment #4, ethics approval march 28, 2007)
boolean
C0201976 (UMLS CUI [1])
Hematology | Absolute neutrophil count | Hemoglobin | Gender
Item
5. hematology outside of specified limits: neutrophil count < 1000/mm3, hemoglobin < 10 g/l in males and < 9 g/l in females
boolean
C0474523 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Thyroid Diseases Unstable | Thyroid Diseases Uncontrolled | Interferon therapy | Ribavirin | Vasculitis Clinical Significance Due to Cryoglobulinemia | Exanthema Due to Cryoglobulinemia | Arthritis Due to Cryoglobulinemia | Renal Insufficiency Due to Cryoglobulinemia | Hepatitis, Autoimmune | alpha 1-Antitrypsin Deficiency | Hereditary hemochromatosis | Hepatolenticular Degeneration | Drug-induced disorder of liver | Liver diseases Due to Toxin | Alcoholic Liver Diseases | Primary biliary cirrhosis | Cholangitis, Sclerosing
Item
7. unstable or uncontrolled thyroid disease 8. treatment with interferon- and/or ribavirin within the previous 12 months 9. presence of clinically significant cryoglobulinemia vasculitis (e.g. skin rash, arthritis, or renal insufficiency due to cryoglobulinemia) 10. presence or history of autoimmune hepatitis, alpha-1-anti-trypsin deficiency, genetic hemochromatosis, wilson disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis.
boolean
C0040128 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0279030 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C0042384 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0678226 (UMLS CUI [5,3])
C0010403 (UMLS CUI [5,4])
C0015230 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0010403 (UMLS CUI [6,3])
C0003864 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0010403 (UMLS CUI [7,3])
C1565489 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0010403 (UMLS CUI [8,3])
C0241910 (UMLS CUI [9])
C0221757 (UMLS CUI [10])
C0392514 (UMLS CUI [11])
C0019202 (UMLS CUI [12])
C0860207 (UMLS CUI [13])
C0023895 (UMLS CUI [14,1])
C0678226 (UMLS CUI [14,2])
C0040549 (UMLS CUI [14,3])
C0023896 (UMLS CUI [15])
C0008312 (UMLS CUI [16])
C0008313 (UMLS CUI [17])
Hepatitis B, Chronic | Hepatitis B surface antigen positive | HIV Infections | HIV TEST WESTERN BLOT POSITIVE
Item
11. chronic hepatitis b infection or positive hbsag at screening 12. known history of hiv infection or positive hiv antibody test by western blot.
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0745009 (UMLS CUI [4])
Disease Causing Immune System Processes Alteration Significant | Hematologic Neoplasms | Autoimmune Diseases
Item
13. a disease known to cause significant alteration in immunologic function, including hematological malignancy or autoimmune disorder.
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1817756 (UMLS CUI [1,3])
C1515926 (UMLS CUI [1,4])
C0750502 (UMLS CUI [1,5])
C0376545 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
Immunosuppressive Agents | Cytotoxic agent | Prednisone | Cyclosporine | Azathioprine | Antineoplastic Agents
Item
14. concurrent therapy with immunosuppressive drugs or cytotoxic agents, such as prednisone, cyclosporine, azathioprine or chemotherapeutic agents.
boolean
C0021081 (UMLS CUI [1])
C0304497 (UMLS CUI [2])
C0032952 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0004482 (UMLS CUI [5])
C0003392 (UMLS CUI [6])
Heart Diseases Unstable | Lung diseases Unstable | Kidney Diseases Unstable | Heart Diseases Worsening | Lung diseases Worsening | Kidney Diseases Worsening | Mental disorders | Severe depression | Psychotic Disorders Major | Feeling suicidal | Suicide attempt
Item
15. history of unstable or deteriorating cardiac, pulmonary or renal disease. 16. preexisting (within last two years) or active psychiatric condition including severe untreated depression, major psychoses, suicidal ideation or suicidal attempts.
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
C0024115 (UMLS CUI [5,1])
C0332271 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0332271 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7])
C0588008 (UMLS CUI [8])
C0033975 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
C0424000 (UMLS CUI [10])
C0038663 (UMLS CUI [11])
Diabetes Mellitus Severe | Diabetes mellitus poor control | Disease Serious Affecting safety assessment | Disease Serious Affecting Evaluation | Chronic disease Affecting safety assessment | Chronic disease Affecting Evaluation
Item
17. severe or poorly controlled diabetes mellitus 18. any serious or chronic disease that may affect the assessment of safety or efficacy parameters.
boolean
C0011849 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0860161 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C1161149 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0220825 (UMLS CUI [4,4])
C0008679 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1161149 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0220825 (UMLS CUI [6,3])
Transplantation of liver | Hepatitis C virus genotype | Injecting drug user
Item
19. patients who have had a liver transplant 20. patients infected with hcv genotypes 4, 5 or 6 (< 1% of infected current/past idus)
boolean
C0023911 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
C0556025 (UMLS CUI [3])
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