ID

29744

Beskrivning

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced; ODM derived from: https://clinicaltrials.gov/show/NCT00793793

Länk

https://clinicaltrials.gov/show/NCT00793793

Nyckelord

Versioner (2)
  1. 2018-04-18 2018-04-18 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00793793

Engelsk

Eligibility Hepatitis C, Chronic NCT00793793

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1a. for treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis c infection
Beskrivning

Patients Therapy naive | Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Hepatitis C | Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0524910
1b. for treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. age 18 years or older 3. signed informed consent form prior to trial participation 4. male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. chronic hepatitis c infection of genotype 1, diagnosed by positive hcv serology test (hcv ab positive) or detectable hcv rna at least 6 months prior to screening 6. hcv viral load >= 100,000 iu/ml at screening 7. tsh and t4 within normal limits or adequately controlled thyroid function 8. histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (ishak grade 1-4 or metavir grade 1-3)
Beskrivning

Patients Therapeutic procedure Experience | Failure virologic | Peginterferon alfa-2a Dose | Peginterferon alfa-2b Dose | Ribavirin Dose | Washout Period | Medical History | Age | Informed Consent | Gender | Hysterectomy | Menopausal Status | Last menstrual period | Chronic Hepatitis C HCV genotype determination | Hepatitis C virus Serology positive | Hepatitis C antibody positive | Hepatitis C virus RNA Detectable | HCV Viral load measurement | Serum TSH level normal | Serum T4 level normal | Thyroid function Controlled | Necroinflammatory activity grade chronic | Fibrosis Ishak Score | Fibrosis METAVIR Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0596545
UMLS CUI [2,1]
C0231174
UMLS CUI [2,2]
C0205466
UMLS CUI [3,1]
C0391001
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0796545
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0035525
UMLS CUI [5,2]
C0178602
UMLS CUI [6]
C1710661
UMLS CUI [7]
C0262926
UMLS CUI [8]
C0001779
UMLS CUI [9]
C0021430
UMLS CUI [10]
C0079399
UMLS CUI [11]
C0020699
UMLS CUI [12]
C1513126
UMLS CUI [13]
C0425932
UMLS CUI [14,1]
C0524910
UMLS CUI [14,2]
C1533728
UMLS CUI [15,1]
C0220847
UMLS CUI [15,2]
C0242089
UMLS CUI [16]
C0281863
UMLS CUI [17,1]
C0369335
UMLS CUI [17,2]
C3830527
UMLS CUI [18,1]
C0220847
UMLS CUI [18,2]
C1261478
UMLS CUI [19]
C0580433
UMLS CUI [20]
C0580330
UMLS CUI [21,1]
C2242456
UMLS CUI [21,2]
C2587213
UMLS CUI [22,1]
C1954433
UMLS CUI [22,2]
C0205191
UMLS CUI [23,1]
C0016059
UMLS CUI [23,2]
C2986945
UMLS CUI [24,1]
C0016059
UMLS CUI [24,2]
C3897040
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis c infection
Beskrivning

Protease Inhibitors Dose Quantity | Hepatitis C | Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033607
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0524910
2. evidence of liver disease due to causes other than chronic hcv infection
Beskrivning

Liver disease | Causes Except Chronic Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0524910
3. positive elisa for hiv-1 or hiv-2
Beskrivning

ELISA Positive HIV-1 | ELISA Positive HIV-2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014441
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0019704
UMLS CUI [2,1]
C0014441
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0019707
4. hepatitis b virus (hbv) infection based on presence of hbs ag or hbv dna
Beskrivning

Hepatitis B | Hepatitis B Surface Antigens Present | Hepatitis B virus DNA Present

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C0369332
UMLS CUI [3,2]
C0150312
5. any previous liver biopsy consistent with cirrhosis
Beskrivning

Biopsy of liver Consistent with Liver Cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0023890
6. decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy
Beskrivning

Decompensated liver disease | Ascites | Hypertension, Portal | Icterus | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0020541
UMLS CUI [4]
C0022346
UMLS CUI [5]
C0019151
7. haemophilia
Beskrivning

Hemophilia

Datatyp

boolean

Alias
UMLS CUI [1]
C0684275
8. hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
Beskrivning

Hemoglobinopathy | Thalassemia major | Anemia, Sickle Cell

Datatyp

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0002875
UMLS CUI [3]
C0002895
9. severe pre-existing psychiatric disease
Beskrivning

Severe Mental Disorder Pre-existing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4046029
UMLS CUI [1,2]
C2347662
10. poorly controlled diabetes mellitus
Beskrivning

Poorly controlled diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0554876
11. ischaemic heart disease
Beskrivning

Myocardial Ischemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0151744
12. chronic obstructive airway disease
Beskrivning

Chronic Obstructive Airway Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0024117
13. autoimmune disease; including autoimmune hepatitis
Beskrivning

Autoimmune Diseases | Hepatitis, Autoimmune

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0241910
14. history of alcohol abuse within the past 12 months
Beskrivning

Alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
15. hyperbilirubinemia (conjugated bilirubin) >1.5x uln
Beskrivning

Hyperbilirubinemia | Bilirubin conjugated increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0020433
UMLS CUI [2]
C0855625
16. alkaline phosphatase >1.5x uln
Beskrivning

Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0151849
17. alt and ast levels >= 5 x uln
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
18. hemoglobin < 12.0 g/dl for women and < 13.0 g/dl for men
Beskrivning

Hemoglobin measurement | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
19. white blood cell count < 2000 cells/mm3
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
20. absolute neutrophil count < 1500 cells/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
21. platelet count < 100,000 cells/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
22. prothrombin time inr (institutional normalized ratio) prolonged to > 1.5 x uln
Beskrivning

Prothrombin time international normalized ratio (PT-INR) Prolonged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1821762
UMLS CUI [1,2]
C0439590
23. usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study
Beskrivning

Investigational New Drugs | Investigational New Drugs Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1301732
24. known hypersensitivity to study drugs
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Hepatitis C, Chronic NCT00793793

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Patients Therapy naive | Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent | Hepatitis C | Hepatitis C, Chronic
Item
1a. for treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis c infection
boolean
C0030705 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0982327 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0035525 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0019196 (UMLS CUI [5])
C0524910 (UMLS CUI [6])
Patients Therapeutic procedure Experience | Failure virologic | Peginterferon alfa-2a Dose | Peginterferon alfa-2b Dose | Ribavirin Dose | Washout Period | Medical History | Age | Informed Consent | Gender | Hysterectomy | Menopausal Status | Last menstrual period | Chronic Hepatitis C HCV genotype determination | Hepatitis C virus Serology positive | Hepatitis C antibody positive | Hepatitis C virus RNA Detectable | HCV Viral load measurement | Serum TSH level normal | Serum T4 level normal | Thyroid function Controlled | Necroinflammatory activity grade chronic | Fibrosis Ishak Score | Fibrosis METAVIR Score
Item
1b. for treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. age 18 years or older 3. signed informed consent form prior to trial participation 4. male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. chronic hepatitis c infection of genotype 1, diagnosed by positive hcv serology test (hcv ab positive) or detectable hcv rna at least 6 months prior to screening 6. hcv viral load >= 100,000 iu/ml at screening 7. tsh and t4 within normal limits or adequately controlled thyroid function 8. histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (ishak grade 1-4 or metavir grade 1-3)
boolean
C0030705 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0596545 (UMLS CUI [1,3])
C0231174 (UMLS CUI [2,1])
C0205466 (UMLS CUI [2,2])
C0391001 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0796545 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0035525 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C1710661 (UMLS CUI [6])
C0262926 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
C0021430 (UMLS CUI [9])
C0079399 (UMLS CUI [10])
C0020699 (UMLS CUI [11])
C1513126 (UMLS CUI [12])
C0425932 (UMLS CUI [13])
C0524910 (UMLS CUI [14,1])
C1533728 (UMLS CUI [14,2])
C0220847 (UMLS CUI [15,1])
C0242089 (UMLS CUI [15,2])
C0281863 (UMLS CUI [16])
C0369335 (UMLS CUI [17,1])
C3830527 (UMLS CUI [17,2])
C0220847 (UMLS CUI [18,1])
C1261478 (UMLS CUI [18,2])
C0580433 (UMLS CUI [19])
C0580330 (UMLS CUI [20])
C2242456 (UMLS CUI [21,1])
C2587213 (UMLS CUI [21,2])
C1954433 (UMLS CUI [22,1])
C0205191 (UMLS CUI [22,2])
C0016059 (UMLS CUI [23,1])
C2986945 (UMLS CUI [23,2])
C0016059 (UMLS CUI [24,1])
C3897040 (UMLS CUI [24,2])
Item Group
C0680251 (UMLS CUI)
Protease Inhibitors Dose Quantity | Hepatitis C | Chronic Hepatitis C
Item
1. patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis c infection
boolean
C0033607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0019196 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Liver disease | Causes Except Chronic Hepatitis C
Item
2. evidence of liver disease due to causes other than chronic hcv infection
boolean
C0023895 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0524910 (UMLS CUI [2,3])
ELISA Positive HIV-1 | ELISA Positive HIV-2
Item
3. positive elisa for hiv-1 or hiv-2
boolean
C0014441 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0019704 (UMLS CUI [1,3])
C0014441 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0019707 (UMLS CUI [2,3])
Hepatitis B | Hepatitis B Surface Antigens Present | Hepatitis B virus DNA Present
Item
4. hepatitis b virus (hbv) infection based on presence of hbs ag or hbv dna
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0369332 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Biopsy of liver Consistent with Liver Cirrhosis
Item
5. any previous liver biopsy consistent with cirrhosis
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0023890 (UMLS CUI [1,3])
Decompensated liver disease | Ascites | Hypertension, Portal | Icterus | Hepatic Encephalopathy
Item
6. decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0020541 (UMLS CUI [3])
C0022346 (UMLS CUI [4])
C0019151 (UMLS CUI [5])
Hemophilia
Item
7. haemophilia
boolean
C0684275 (UMLS CUI [1])
Hemoglobinopathy | Thalassemia major | Anemia, Sickle Cell
Item
8. hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)
boolean
C0019045 (UMLS CUI [1])
C0002875 (UMLS CUI [2])
C0002895 (UMLS CUI [3])
Severe Mental Disorder Pre-existing
Item
9. severe pre-existing psychiatric disease
boolean
C4046029 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Poorly controlled diabetes mellitus
Item
10. poorly controlled diabetes mellitus
boolean
C0554876 (UMLS CUI [1])
Myocardial Ischemia
Item
11. ischaemic heart disease
boolean
C0151744 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
12. chronic obstructive airway disease
boolean
C0024117 (UMLS CUI [1])
Autoimmune Diseases | Hepatitis, Autoimmune
Item
13. autoimmune disease; including autoimmune hepatitis
boolean
C0004364 (UMLS CUI [1])
C0241910 (UMLS CUI [2])
Alcohol abuse
Item
14. history of alcohol abuse within the past 12 months
boolean
C0085762 (UMLS CUI [1])
Hyperbilirubinemia | Bilirubin conjugated increased
Item
15. hyperbilirubinemia (conjugated bilirubin) >1.5x uln
boolean
C0020433 (UMLS CUI [1])
C0855625 (UMLS CUI [2])
Alkaline phosphatase raised
Item
16. alkaline phosphatase >1.5x uln
boolean
C0151849 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
17. alt and ast levels >= 5 x uln
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Hemoglobin measurement | Gender
Item
18. hemoglobin < 12.0 g/dl for women and < 13.0 g/dl for men
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure
Item
19. white blood cell count < 2000 cells/mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
20. absolute neutrophil count < 1500 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
21. platelet count < 100,000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Prothrombin time international normalized ratio (PT-INR) Prolonged
Item
22. prothrombin time inr (institutional normalized ratio) prolonged to > 1.5 x uln
boolean
C1821762 (UMLS CUI [1,1])
C0439590 (UMLS CUI [1,2])
Investigational New Drugs | Investigational New Drugs Planned
Item
23. usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs
Item
24. known hypersensitivity to study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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