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])
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])