ID

44063

Description

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

Link

https://clinicaltrials.gov/show/NCT00793793

Keywords

Versions (2)
  1. 4/18/18 4/18/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00793793

English

Eligibility Hepatitis C, Chronic NCT00793793

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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)
Description

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

Data type

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]
C3829127
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
Description

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
Description

Protease Inhibitors Dose Quantity | Hepatitis C | Chronic Hepatitis C

Data type

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
Description

Liver disease | Causes Except Chronic Hepatitis C

Data type

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
Description

ELISA Positive HIV-1 | ELISA Positive HIV-2

Data type

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
Description

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

Data type

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
Description

Biopsy of liver Consistent with Liver Cirrhosis

Data type

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
Description

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

Data type

boolean

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

Hemophilia

Data type

boolean

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

Hemoglobinopathy | Thalassemia major | Anemia, Sickle Cell

Data type

boolean

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

Severe Mental Disorder Pre-existing

Data type

boolean

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

Poorly controlled diabetes mellitus

Data type

boolean

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

Myocardial Ischemia

Data type

boolean

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

Chronic Obstructive Airway Disease

Data type

boolean

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

Autoimmune Diseases | Hepatitis, Autoimmune

Data type

boolean

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

Alcohol abuse

Data type

boolean

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

Hyperbilirubinemia | Bilirubin conjugated increased

Data type

boolean

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

Alkaline phosphatase raised

Data type

boolean

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

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

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
Description

Hemoglobin measurement | Gender

Data type

boolean

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

White Blood Cell Count procedure

Data type

boolean

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

Absolute neutrophil count

Data type

boolean

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

Platelet Count measurement

Data type

boolean

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

Prothrombin time international normalized ratio (PT-INR) Prolonged

Data type

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
Description

Investigational New Drugs | Investigational New Drugs Planned

Data type

boolean

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

Hypersensitivity Investigational New Drugs

Data type

boolean

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

Eligibility Hepatitis C, Chronic NCT00793793

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
C3829127 (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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