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

NCT ID: NCT00910624

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-22
• Study Completion Date: 2012-12-07

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 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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BOC + PEG/RBV

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO)

Peginterferon alfa-2b (SCH 54031)

Intervention Type: BIOLOGICAL

Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)

Ribavirin (SCH 18908)

Intervention Type: DRUG

Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

Interventions

Boceprevir

Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO)

Intervention Type: DRUG

Peginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)

Intervention Type: BIOLOGICAL

Ribavirin (SCH 18908)

Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

Intervention Type: DRUG

Other Intervention Names

SCH 503034; PegIntron, PEG; Rebetol, RBV

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Vierling JM, Davis M, Flamm S, Gordon SC, Lawitz E, Yoshida EM, Galati J, Luketic V, McCone J, Jacobson I, Marcellin P, Muir AJ, Poordad F, Pedicone LD, Albrecht J, Brass C, Howe AY, Colvard LY, Helmond FA, Deng W, Treitel M, Wahl J, Bronowicki JP. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response. J Hepatol. 2014 Apr;60(4):748-56. doi: 10.1016/j.jhep.2013.12.013. Epub 2013 Dec 19.

Reference Type: RESULT

PMID: 24362076 (View on PubMed)

Other Identifiers

P05514

Identifier Type: -

Identifier Source: org_study_id