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Hepatitis C, ChronicPhase 3NCT00708500

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

A Phase 3 study testing Boceprevir (SCH 503034), Pegylated interferon alfa-2b (SCH 54031) and Ribavirin (SCH 18908) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Boceprevir (SCH 503034), Pegylated interferon alfa-2b (SCH 54031) and Ribavirin (SCH 18908)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
No sites listed yet
Study dates
Aug 2008to Apr 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Qualifying regimen defined as pegylated interferon alfa-2a plus ribavirin or pegylated interferon alfa-2b plus ribavirin for a minimum of 12 weeks.
  • During qualifying regimen, participants must have either a documented undetectable HCV-RNA within 30 days of end of treatment (EOT) and a subsequent detectable HCV-RNA during follow-up or a documented decline in HCV-RNA by >=2 log10 by Treatment Week 12
  • Previously documented CHC genotype 1 infection.
  • Liver biopsy with histology consistent with CHC and no other etiology.
  • Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
  • Participants participating in Schering-Plough Research Institute (SPRI) maintenance protocols P02570 (NCT00049842) or P02569 (NCT00048724) must have completed the study to be eligible for this protocol.
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  • Participants must be >=18 years of age.
  • Participants must weigh between 40 kg and 125 kg.
  • Participants and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
  • Participants must be willing to give written informed consent.

Who cannot join

  • Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B Surface Antigen [HBsAg] positive).
  • Discontinuation of previous interferon or ribavirin regimen for an adverse event (AE) considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
  • Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
  • Treatment for hepatitis C with any investigational medication. Prior treatment with herbal remedies with known hepatotoxicity.
  • Treatment with any investigational drug within 30 days of the randomization visit.
  • Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial.
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  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Diabetic and/or hypertensive participants with clinically significant ocular examination findings.
  • Pre-existing psychiatric conditions.
  • Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes
  • Any known pre-existing medical condition that could interfere with the participant's participation in and completion of the study.
  • Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Participants under evaluation for malignancy are not eligible.
  • Participants who are pregnant or nursing. Participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
  • Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
  • Participants who are part of the site personnel directly involved with this study.
  • Participants who are family members of the investigational study staff.
  • Participants who had life-threatening serious adverse event (SAE) during screening period.
  • Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (Blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN).
  • Serum albumin <lower limit of normal (LLN)
  • Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range, with certain exceptions.
  • Serum creatinine >ULN of the laboratory reference.
  • Protocol-specified serum glucose concentrations.
  • Protocol-specified alpha fetoprotein range.
  • Prothrombin Time/Partial Thromboplastin Time (PT/PTT) values >10% above laboratory reference range.
  • Anti-nuclear antibodies (ANA) >1:320.

About this study

Official title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA [HCV-RNA] viral load >=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.

Being tested
Boceprevir (SCH 503034), Pegylated interferon alfa-2b (SCH 54031), Ribavirin (SCH 18908), Boceprevir placebo
Keywords
Treatment failure
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boceprevir (SCH 503034)Drug

    Boceprevir, 200 mg capsules, 800 mg TID PO

  • Pegylated interferon alfa-2b (SCH 54031)Biological

    Also called PegIntron, PEG2b

    PEG2b 1.5 μg/kg/week subcutaneously (SC)

  • Ribavirin (SCH 18908)Drug

    Also called Rebetol, RBV

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

  • Boceprevir placeboDrug

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

Study groups in NCT00708500
Study groupRoleWhat they receive
Placebo+PEG2b+RBV, x 44 weeksPlacebo comparatorParticipants 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.
Receives: Biological: Pegylated interferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908); Drug: Boceprevir placebo
Boceprevir+PEG2b+RBV, Response Guided TherapyExperimentalParticipants 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.
Receives: Drug: Boceprevir (SCH 503034); Biological: Pegylated interferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908); Drug: Boceprevir placebo
Boceprevir+PEG2b+RBV, x 44 weeksExperimentalParticipants 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.
Receives: Drug: Boceprevir (SCH 503034); Biological: Pegylated interferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Follow-up Week 24

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00708500
Sponsor's protocol ID
P05101
Other IDs
2007-005151-42
Status last verified
Mar 2017
First submitted
27 Jun 2008
Last updated
7 Apr 2017
Data monitoring committee
Yes
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boceprevir (SCH 503034), Pegylated interferon alfa-2b (SCH 54031) and Ribavirin (SCH 18908) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (time frame: At Follow-up Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708500, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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