ID

27888

Description

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00722358

Link

https://clinicaltrials.gov/show/NCT00722358

Keywords

Versions (1)
  1. 12/4/17 12/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00722358

English

Eligibility Chronic Hepatitis C NCT00722358

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronically infected with hcv genotype 1
Description

Chronic hepatitis C genotype 1

Data type

boolean

Alias
UMLS CUI [1]
C4049392
treatment naive
Description

Therapy naive

Data type

boolean

Alias
UMLS CUI [1]
C0919936
hcv rna viral load of ≥10*5 iu/ml
Description

Hepatitis C virus RNA assay

Data type

boolean

Alias
UMLS CUI [1]
C1272251
bmi 18 to 35kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential (wocbp)
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hcv infection
Description

Illness Unstable | Chronic disease Unstable | Illness Pharmaceutical Preparations Uncontrolled | Chronic disease Pharmaceutical Preparations Uncontrolled | Illness Inconsistent Hepatitis C | Chronic disease Inconsistent Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0442809
UMLS CUI [5,3]
C0019196
UMLS CUI [6,1]
C0008679
UMLS CUI [6,2]
C0442809
UMLS CUI [6,3]
C0019196
hcv infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of soc and continue to have a detectable hcv rna level or subjects who did not attain a 2-log decline in hcv rna levels at 12 weeks and stopped treatment
Description

Hepatitis C Unresponsive to Treatment | Standard of Care | Hepatitis C virus RNA Detectable | Other Coding | Therapeutic procedure Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C2936643
UMLS CUI [3,1]
C0369335
UMLS CUI [3,2]
C3830527
UMLS CUI [4]
C3846158
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1444662
hcv infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of soc due to toxicities associated with interferon and/or ribavirin
Description

Hepatitis C | Therapeutic procedure intolerant | Standard of Care Receive Unable | Toxicity Associated with Interferon | Toxicity Associated with Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0231200
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0021747
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0035525
hiv and/or hbv positive
Description

HIV Seropositivity | Hepatitis B virus test positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
Description

Major surgery | Gastrointestinal Surgical Procedure Impact Absorption Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Chronic Hepatitis C NCT00722358

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic hepatitis C genotype 1
Item
chronically infected with hcv genotype 1
boolean
C4049392 (UMLS CUI [1])
Therapy naive
Item
treatment naive
boolean
C0919936 (UMLS CUI [1])
Hepatitis C virus RNA assay
Item
hcv rna viral load of ≥10*5 iu/ml
boolean
C1272251 (UMLS CUI [1])
Body mass index
Item
bmi 18 to 35kg/m²
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential
Item
women of childbearing potential (wocbp)
boolean
C3831118 (UMLS CUI [1])
Illness Unstable | Chronic disease Unstable | Illness Pharmaceutical Preparations Uncontrolled | Chronic disease Pharmaceutical Preparations Uncontrolled | Illness Inconsistent Hepatitis C | Chronic disease Inconsistent Hepatitis C
Item
any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hcv infection
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0008679 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0221423 (UMLS CUI [5,1])
C0442809 (UMLS CUI [5,2])
C0019196 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0442809 (UMLS CUI [6,2])
C0019196 (UMLS CUI [6,3])
Hepatitis C Unresponsive to Treatment | Standard of Care | Hepatitis C virus RNA Detectable | Other Coding | Therapeutic procedure Discontinued
Item
hcv infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of soc and continue to have a detectable hcv rna level or subjects who did not attain a 2-log decline in hcv rna levels at 12 weeks and stopped treatment
boolean
C0019196 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2])
C0369335 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
Hepatitis C | Therapeutic procedure intolerant | Standard of Care Receive Unable | Toxicity Associated with Interferon | Toxicity Associated with Ribavirin
Item
hcv infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of soc due to toxicities associated with interferon and/or ribavirin
boolean
C0019196 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0231200 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0600688 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0021747 (UMLS CUI [4,3])
C0600688 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0035525 (UMLS CUI [5,3])
HIV Seropositivity | Hepatitis B virus test positive
Item
hiv and/or hbv positive
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
Major surgery | Gastrointestinal Surgical Procedure Impact Absorption Investigational New Drugs
Item
major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
boolean
C0679637 (UMLS CUI [1])
C0524722 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
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