Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Keywords

• Treatment failure

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 404 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Placebo comparator
  Placebo+PEG2b+RBV, x 44 weeks

  Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

  Biological: Pegylated interferon alfa-2b (SCH 54031) · Drug: Ribavirin (SCH 18908) · Drug: Boceprevir placebo

• Experimental
  Boceprevir+PEG2b+RBV, Response Guided Therapy

  Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8. PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then: * 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up. * 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.

  Drug: Boceprevir (SCH 503034) · Biological: Pegylated interferon alfa-2b (SCH 54031) · Drug: Ribavirin (SCH 18908) · Drug: Boceprevir placebo

• Experimental
  Boceprevir+PEG2b+RBV, x 44 weeks

  Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

  Drug: Boceprevir (SCH 503034) · Biological: Pegylated interferon alfa-2b (SCH 54031) · Drug: Ribavirin (SCH 18908)

Interventions

• DrugBoceprevir (SCH 503034)

  Boceprevir, 200 mg capsules, 800 mg TID PO

• BiologicalPegylated interferon alfa-2b (SCH 54031)

  PEG2b 1.5 μg/kg/week subcutaneously (SC)

  Also known as: PegIntron, PEG2b

• DrugRibavirin (SCH 18908)

  Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID).

  Also known as: Rebetol, RBV

• DrugBoceprevir placebo

  Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO.

Primary outcomes

1. Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.

   SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.

   Time frame: At Follow-up Week 24

Secondary outcomes

1. Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.

   SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment. This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009.

   Time frame: At Follow-up Week 24

2. Number of Participants With Early Virologic Response.

   Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.

   Time frame: At Week 2, 4, 8, or 12

3. Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.

   Time frame: At Follow-up Week 12 and at 72 weeks after randomization

Baseline characteristics

Publications

• Poordad F, Bronowicki JP, Gordon SC, Zeuzem S, Jacobson IM, Sulkowski MS, Poynard T, Morgan TR, Molony C, Pedicone LD, Sings HL, Burroughs MH, Sniukiene V, Boparai N, Goteti VS, Brass CA, Albrecht JK, Bacon BR; SPRINT-2 and RESPOND-2 Investigators. Factors that predict response of patients with hepatitis C virus infection to boceprevir. Gastroenterology. 2012 Sep;143(3):608-618.e5. doi: 10.1053/j.gastro.2012.05.011. Epub 2012 May 21. PubMed 22626609 ↗
• Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482. PubMed 21449784 ↗

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php