ID

17550

Beskrivning

Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02254707

Länk

https://clinicaltrials.gov/show/NCT02254707

Nyckelord

Versioner (1)
  1. 2016-09-23 2016-09-23 -
Uppladdad den

23 september 2016

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT02254707

Engelsk

Eligibility Hepatitis C, Chronic NCT02254707

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult males from 18 - 65 years
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
2. written informed consent consistent with ich (international conference on harmonisation)/gcp (good clinical practice) and local legislation given prior to any study procedures
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. chronic hcv infection demonstrated by positive hcv igg antibody
Beskrivning

Hepatitis C, Chronic | Hepatitis C Antibodies Immunoglobulin G Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C0020852
UMLS CUI [2,3]
C1514241
4. hcv genotype 1 which has to be confirmed by central laboratory test before visit 2
Beskrivning

Hepatitis C virus genotype

Datatyp

boolean

Alias
UMLS CUI [1]
C1148363
5. liver biopsy consistent with active hepatitis c virus (hcv) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (ishak or metavir grade <= 2)
Beskrivning

Biopsy of liver Consistent with Hepatitis C | Liver Fibrosis Minimal | Liver Fibrosis Mild | Liver Cirrhosis | Ishak Score | Metavir score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0019196
UMLS CUI [2,1]
C0239946
UMLS CUI [2,2]
C0547040
UMLS CUI [3,1]
C0239946
UMLS CUI [3,2]
C2945599
UMLS CUI [4]
C0023890
UMLS CUI [5]
C2986945
UMLS CUI [6]
C3888527
6. hcv ribonucleic acid (rna) load greater than 100,000 iu rna per ml serum at screening
Beskrivning

HCV viral load

Datatyp

boolean

Alias
UMLS CUI [1]
C1868902
7. willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)
Beskrivning

Alcohol Abstinence Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (iud).
Beskrivning

Gender Contraceptive methods | Childbearing Potential Partner | Condoms, Male | Male sterilization | Hormonal contraception | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Intrauterine Devices

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0682323
UMLS CUI [3]
C0009653
UMLS CUI [4]
C0024559
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0009907
UMLS CUI [7]
C1656586
UMLS CUI [8]
C1657106
UMLS CUI [9]
C0021900
2. any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
Beskrivning

Chronic liver disease Etiology aspects | Virus Causing Hepatitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0015127
UMLS CUI [2,1]
C0042776
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0019158
3. evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
Beskrivning

Decompensated liver disease Evidence of | Ascites | Hypertension, Portal | Hepatic Encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0020541
UMLS CUI [4]
C0019151
4. positive test for human immunodeficiency virus (hiv) or hepatitis b surface (hbs) antigen at screening
Beskrivning

HIV Seropositivity | Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
5. current alcohol or drug abuse, or history of the same, within the past twelve (12) months. all patients must abstain from alcohol from enrolment until completion of the study (visit 11).
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
6. any concurrent medical illness or disease requiring treatment or concomitant medications
Beskrivning

Comorbidity Requirement Therapeutic procedure | Comorbidity Requirement Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013227
7. history of malignancy (except for previously cured squamous cell or basal cell carcinoma)
Beskrivning

Malignant Neoplasms | Squamous cell carcinoma cured | Basal cell carcinoma cured

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0679252
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C0679252
8. usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
9. patients treated with interferon and/or ribavirin within 6 months prior to screening
Beskrivning

interferon | Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1]
C0733470
UMLS CUI [2]
C0035525
10. planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
Beskrivning

Pharmacotherapy | Antiviral Therapy | Vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0280274
UMLS CUI [3]
C0042196
11. known hypersensitivity to drugs or excipients
Beskrivning

Drug Allergy | Hypersensitivity Pharmaceutical Excipient

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
12. patients with any one of the following laboratory values at screening:
Beskrivning

Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
alanine transaminase (alt) or aspartate transaminase (ast) > 2.5 x upper limit of normal (uln) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin > 1x uln
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
alkaline phosphatase > 1.5x uln
Beskrivning

Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
prothrombin time (inr, prolonged) > 1.5
Beskrivning

Prothrombin time | INR | Prothrombin time increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0151872
platelet count < 100,000 / mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin < 10.5 g/dl
Beskrivning

Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
white blood cell count < 2,000 / mm3
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
13. patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
Beskrivning

LABORATORY ABNORMALITIES Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C2826293
14. positive urine test for drug abuse at screening
Beskrivning

Urinalysis Positive Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0013146
15. patients with known gilbert's disease
Beskrivning

Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0017551
16. prior randomisation to active treatment with bilb 1941 zw into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. to support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
17. inability to comply with the protocol
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Hepatitis C, Chronic NCT02254707

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
1. adult males from 18 - 65 years
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. written informed consent consistent with ich (international conference on harmonisation)/gcp (good clinical practice) and local legislation given prior to any study procedures
boolean
C0021430 (UMLS CUI [1])
Hepatitis C, Chronic | Hepatitis C Antibodies Immunoglobulin G Positive
Item
3. chronic hcv infection demonstrated by positive hcv igg antibody
boolean
C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Hepatitis C virus genotype
Item
4. hcv genotype 1 which has to be confirmed by central laboratory test before visit 2
boolean
C1148363 (UMLS CUI [1])
Biopsy of liver Consistent with Hepatitis C | Liver Fibrosis Minimal | Liver Fibrosis Mild | Liver Cirrhosis | Ishak Score | Metavir score
Item
5. liver biopsy consistent with active hepatitis c virus (hcv) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (ishak or metavir grade <= 2)
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0239946 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C0239946 (UMLS CUI [3,1])
C2945599 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4])
C2986945 (UMLS CUI [5])
C3888527 (UMLS CUI [6])
HCV viral load
Item
6. hcv ribonucleic acid (rna) load greater than 100,000 iu rna per ml serum at screening
boolean
C1868902 (UMLS CUI [1])
Alcohol Abstinence Willing
Item
7. willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)
boolean
C0678274 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gender Contraceptive methods | Childbearing Potential Partner | Condoms, Male | Male sterilization | Hormonal contraception | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Intrauterine Devices
Item
1. males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (iud).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0009653 (UMLS CUI [3])
C0024559 (UMLS CUI [4])
C2985296 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
Chronic liver disease Etiology aspects | Virus Causing Hepatitis
Item
2. any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
boolean
C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0042776 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019158 (UMLS CUI [2,3])
Decompensated liver disease Evidence of | Ascites | Hypertension, Portal | Hepatic Encephalopathy
Item
3. evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
boolean
C4075847 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0020541 (UMLS CUI [3])
C0019151 (UMLS CUI [4])
HIV Seropositivity | Hepatitis B surface antigen positive
Item
4. positive test for human immunodeficiency virus (hiv) or hepatitis b surface (hbs) antigen at screening
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Substance Use Disorders
Item
5. current alcohol or drug abuse, or history of the same, within the past twelve (12) months. all patients must abstain from alcohol from enrolment until completion of the study (visit 11).
boolean
C0038586 (UMLS CUI [1])
Comorbidity Requirement Therapeutic procedure | Comorbidity Requirement Pharmaceutical Preparations
Item
6. any concurrent medical illness or disease requiring treatment or concomitant medications
boolean
C0009488 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Malignant Neoplasms | Squamous cell carcinoma cured | Basal cell carcinoma cured
Item
7. history of malignancy (except for previously cured squamous cell or basal cell carcinoma)
boolean
C0006826 (UMLS CUI [1])
C0007137 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C0679252 (UMLS CUI [3,2])
Investigational New Drugs
Item
8. usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
boolean
C0013230 (UMLS CUI [1])
interferon | Ribavirin
Item
9. patients treated with interferon and/or ribavirin within 6 months prior to screening
boolean
C0733470 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
Pharmacotherapy | Antiviral Therapy | Vaccination
Item
10. planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
boolean
C0013216 (UMLS CUI [1])
C0280274 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Drug Allergy | Hypersensitivity Pharmaceutical Excipient
Item
11. known hypersensitivity to drugs or excipients
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Laboratory Results
Item
12. patients with any one of the following laboratory values at screening:
boolean
C1254595 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alanine transaminase (alt) or aspartate transaminase (ast) > 2.5 x upper limit of normal (uln) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin > 1x uln
boolean
C1278039 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase > 1.5x uln
boolean
C0201850 (UMLS CUI [1])
Prothrombin time | INR | Prothrombin time increased
Item
prothrombin time (inr, prolonged) > 1.5
boolean
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0151872 (UMLS CUI [3])
Platelet Count measurement
Item
platelet count < 100,000 / mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin
Item
hemoglobin < 10.5 g/dl
boolean
C0019046 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cell count < 2,000 / mm3
boolean
C0023508 (UMLS CUI [1])
LABORATORY ABNORMALITIES Clinical Significance
Item
13. patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
boolean
C1853129 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Urinalysis Positive Drug abuse
Item
14. positive urine test for drug abuse at screening
boolean
C0042014 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,3])
Gilbert Disease
Item
15. patients with known gilbert's disease
boolean
C0017551 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
16. prior randomisation to active treatment with bilb 1941 zw into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. to support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unable
Item
17. inability to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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