ID

40913

Description

Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514); ODM derived from: https://clinicaltrials.gov/show/NCT00910624

Link

https://clinicaltrials.gov/show/NCT00910624

Keywords

Versions (1)
  1. 6/3/20 6/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00910624

English

Eligibility Hepatitis C, Chronic NCT00910624

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must have been assigned to a peg/rbv control arm in a previous spri study of boc, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study.
Description

Assignment Protocol Arm PEGINTERFERON/RIBAVIRIN | Treatment completed | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1516050
UMLS CUI [1,2]
C1522541
UMLS CUI [1,3]
C1875630
UMLS CUI [2]
C0580352
UMLS CUI [3]
C0525058
participant must have received at least 12 weeks of treatment with peg/rbv and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse.
Description

PEGINTERFERON/RIBAVIRIN Duration of treatment | Therapy Discontinued | Viral Breakthrough | Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C4053869
UMLS CUI [4]
C0035020
participant must have had detectable hcv-rna upon completion of the previous study.
Description

Hepatitis C RNA Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0855840
UMLS CUI [1,2]
C3830527
participant and participant partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations.
Description

Study Subject Contraceptive methods | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
participant must be willing to give written informed consent.
Description

Informed Consent Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all participant exclusion criteria from the spri clinical study in which the participant participated prior to qualifying for this study will apply in this study, except for the following:
Description

Exclusion Criteria Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
treatment with rbv within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in p05514.
Description

Exception Ribavirin | Exception Interferon-alpha

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0035525
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0002199
participation in any other spri clinical trial within 30 days of enrollment in this study is not exclusionary.
Description

Participation Clinical Trial Specified allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C0683607
use of growth factor at the entry of the study is allowed if it was prescribed in the previous study.
Description

Growth Factor allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C0683607
laboratory criteria of thyroid-stimulating hormone (tsh) do not apply. laboratory criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study.
Description

Laboratory Criteria Excluded | TSH | Hemoglobin | Neutrophils | Platelets

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0332196
UMLS CUI [2]
C0040160
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0027950
UMLS CUI [5]
C0005821
participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded
Description

Exception | Moderate depression | Stable status | Well controlled

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2]
C0588007
UMLS CUI [3]
C0205360
UMLS CUI [4]
C3853142
participants who had the opportunity to receive boceprevir in the previous study.
Description

boceprevir

Data type

boolean

Alias
UMLS CUI [1]
C1738934
participants requiring discontinuation, interruption, or dose reduction of rbv for more than 2 weeks in the previous study.
Description

Requirement Ribavirin Discontinuation | Requirement Ribavirin Interruption | Requirement Ribavirin Dose Reduction

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0035525
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0035525
UMLS CUI [2,3]
C1512900
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0035525
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0392756
participants requiring discontinuation, interruption, or dose reduction of peg to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study.
Description

Requirement PEGINTERFERON Discontinuation | Requirement PEGINTERFERON Interruption | Requirement PEGINTERFERON Dose Reduction

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0982327
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0982327
UMLS CUI [2,3]
C1512900
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0982327
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0392756
participants who experienced a life-threatening sae considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
Description

Adverse event Severe Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2826244
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Similar models

Eligibility Hepatitis C, Chronic NCT00910624

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Assignment Protocol Arm PEGINTERFERON/RIBAVIRIN | Treatment completed | Protocol Compliance
Item
participant must have been assigned to a peg/rbv control arm in a previous spri study of boc, must have completed treatment as per protocol, and have been compliant with all study treatment and scheduled procedures within the previous study.
boolean
C1516050 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C1875630 (UMLS CUI [1,3])
C0580352 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
PEGINTERFERON/RIBAVIRIN Duration of treatment | Therapy Discontinued | Viral Breakthrough | Relapse
Item
participant must have received at least 12 weeks of treatment with peg/rbv and must have discontinued treatment in the previous study due to the futility rule (as defined in the previous protocol), had virologic breakthrough, or relapse.
boolean
C1875630 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C4053869 (UMLS CUI [3])
C0035020 (UMLS CUI [4])
Hepatitis C RNA Detectable
Item
participant must have had detectable hcv-rna upon completion of the previous study.
boolean
C0855840 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
Study Subject Contraceptive methods | Partner Contraceptive methods
Item
participant and participant partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs, or longer if dictated by local regulations.
boolean
C0681850 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent Willing
Item
participant must be willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Clinical Trial Specified
Item
all participant exclusion criteria from the spri clinical study in which the participant participated prior to qualifying for this study will apply in this study, except for the following:
boolean
C0680251 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Exception Ribavirin | Exception Interferon-alpha
Item
treatment with rbv within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in p05514.
boolean
C1705847 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0002199 (UMLS CUI [2,2])
Participation Clinical Trial Specified allowed
Item
participation in any other spri clinical trial within 30 days of enrollment in this study is not exclusionary.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0683607 (UMLS CUI [1,4])
Growth Factor allowed
Item
use of growth factor at the entry of the study is allowed if it was prescribed in the previous study.
boolean
C0018284 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
Laboratory Criteria Excluded | TSH | Hemoglobin | Neutrophils | Platelets
Item
laboratory criteria of thyroid-stimulating hormone (tsh) do not apply. laboratory criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met dose reduction/interruption/discontinuation criteria in the previous study.
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0040160 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0027950 (UMLS CUI [4])
C0005821 (UMLS CUI [5])
Exception | Moderate depression | Stable status | Well controlled
Item
participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded
boolean
C1705847 (UMLS CUI [1])
C0588007 (UMLS CUI [2])
C0205360 (UMLS CUI [3])
C3853142 (UMLS CUI [4])
boceprevir
Item
participants who had the opportunity to receive boceprevir in the previous study.
boolean
C1738934 (UMLS CUI [1])
Requirement Ribavirin Discontinuation | Requirement Ribavirin Interruption | Requirement Ribavirin Dose Reduction
Item
participants requiring discontinuation, interruption, or dose reduction of rbv for more than 2 weeks in the previous study.
boolean
C1514873 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0392756 (UMLS CUI [3,4])
Requirement PEGINTERFERON Discontinuation | Requirement PEGINTERFERON Interruption | Requirement PEGINTERFERON Dose Reduction
Item
participants requiring discontinuation, interruption, or dose reduction of peg to less than two-thirds of the assigned starting dose for more than 2 weeks in the previous study.
boolean
C1514873 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C1512900 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0982327 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0392756 (UMLS CUI [3,4])
Adverse event Severe Life Threatening
Item
participants who experienced a life-threatening sae considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
boolean
C0877248 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
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