Status:
COMPLETED
Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who completed their pe...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Participant must have had detectable HCV-RNA upon completion of the previous study.
- 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.
- Participant must be willing to give written informed consent.
Exclusion
- 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:
- Treatment with RBV within 90 days and any interferon-alpha within 1 month of the enrollment is not exclusionary in P05514.
- Participation in any other SPRI clinical trial within 30 days of enrollment in this study is not exclusionary.
- Use of growth factor at the entry of the study is allowed if it was prescribed in the previous study.
- 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.
- Participants who develop moderate depression in the previous study and continue to be stable and well controlled are not excluded
- Participants who had the opportunity to receive boceprevir in the previous study.
- Participants requiring discontinuation, interruption, or dose reduction of RBV for more than 2 weeks in the previous study.
- 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.
- Participants who experienced a life-threatening SAE considered at least possibly related to study drugs by the investigator or sponsor in the previous study.
Key Trial Info
Start Date :
June 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2012
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00910624
Start Date
June 22 2009
End Date
December 7 2012
Last Update
February 8 2021
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