NCT01390844

Brief Summary

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 28, 2016

Completed
Last Updated

September 11, 2018

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

July 7, 2011

Results QC Date

May 20, 2016

Last Update Submit

August 13, 2018

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population

    SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

    Follow-up Week 24

  • Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population

    SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.

    Follow-up Week 24

Secondary Outcomes (8)

  • Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population

    Follow-up Week 24

  • Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population

    Follow-up Week 24

  • Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8

    Treatment Week 8

  • Percentage of Participants in India Achieving EVR at Treatment Week 8

    Treatment Week 8

  • Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan

    Up to 96 weeks

  • +3 more secondary outcomes

Study Arms (2)

Boceprevir

EXPERIMENTAL

PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.

Drug: Boceprevir (BOC)Drug: Placebo to boceprevirDrug: Peginterferon alfa-2b (PEG)Drug: Ribavirin (RBV)

Control

ACTIVE COMPARATOR

PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.

Drug: Placebo to boceprevirDrug: Peginterferon alfa-2b (PEG)Drug: Ribavirin (RBV)Drug: Cross-Over Boceprevir Treatment

Interventions

Boceprevir (BOC)DRUG

200 mg capsules, 800 mg three times daily by mouth

Also known as: SCH 503034, Victrelis
Boceprevir
Placebo to boceprevirDRUG

200 mg placebo capsules, 800 mg three times daily by mouth

BoceprevirControl
Peginterferon alfa-2b (PEG)DRUG

1.5 mcg/kg/week subcutaneously

Also known as: PegIntron, SCH 054031, Redipen
BoceprevirControl
Ribavirin (RBV)DRUG

200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily

Also known as: Rebetol, SCH 018908
BoceprevirControl
Cross-Over Boceprevir TreatmentDRUG

At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.

Also known as: SCH 503034, Victrelis
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
  • Liver biopsy with histology consistent with CHC and no other etiology.
  • Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
  • Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
  • Weight between 40 kg and 125 kg, inclusive
  • Of 'local' ancestral descent
  • Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

You may not qualify if:

  • Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
  • Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
  • Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
  • Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
  • Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Diabetes and/or hypertension with clinically significant ocular examination findings.
  • Any condition the could interfere with participation in and completion of the trial.
  • Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
  • Pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamidepeginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

October 21, 2011

Primary Completion

June 19, 2015

Study Completion

June 19, 2015

Last Updated

September 11, 2018

Results First Posted

June 28, 2016

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information