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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00910624
First received: May 28, 2009
Last updated: March 17, 2014
Last verified: March 2014

May 28, 2009
March 17, 2014
June 2009
December 2012   (final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24); [ Time Frame: From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks) ] [ Designated as safety issue: No ]
    SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.
  • Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL [ Time Frame: From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks) ] [ Designated as safety issue: Yes ]
    AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.
Sustained virologic response (SVR; undetectable HCV-RNA at Follow-up Week 24) after treatment with boceprevir and PEG/RBV in adult CHC genotype 1 subjects who completed treatment and did not achieve SVR in the PEG/RBV control arm of a previous SPRI study [ Time Frame: At Follow-up Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00910624 on ClinicalTrials.gov Archive Site
Percentage of Participants With Early Virologic Response (EVR) [ Time Frame: From TW 1 to TW 12 ] [ Designated as safety issue: No ]
EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.
Proportion of subjects with undetectable HCV-RNA at Treatment Week 12 (early virologic response; EVR) [ Time Frame: At Treatment Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)
A Single-Arm Study to Provide Boceprevir Treatment in Subjects With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Boceprevir
    Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO)
    Other Name: SCH 503034
  • Biological: Peginterferon alfa-2b (SCH 54031)
    Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC)
    Other Name: PegIntron, PEG
  • Drug: Ribavirin (SCH 18908)
    Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
    Other Name: Rebetol, RBV
Experimental: 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.
Interventions:
  • Drug: Boceprevir
  • Biological: Peginterferon alfa-2b (SCH 54031)
  • Drug: Ribavirin (SCH 18908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00910624
P05514
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP