Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514) (PROVIDE)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin (SCH 18908); Drug: Boceprevir; Biological: Peginterferon alfa-2b (SCH 54031)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00910624

P05514

Details and patient eligibility

About

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 per-protocol defined treatment and did not achieve sustained viral response (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI) study of BOC combination therapy. Participants who are able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

BOC + PEG/RBV

Experimental group

Description:

Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous protocol received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Treatment:

Biological: Peginterferon alfa-2b (SCH 54031)

Drug: Boceprevir

Drug: Ribavirin (SCH 18908)