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CompletedNCT01756079Updated Sep 5, 2018Results posted

A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

A Phase 4 interventional study of boceprevir and PegIFN-2b in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.

02

Conditions studied

  • Hepatitis C

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03

In context

Hepatitis C

2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.

This study's enrollment of 58 is below the median of 79 across 1,660 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Weight between 40 kg and 125 kg
  • Documented CHC genotype 1 infection
  • Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
  • Documented diagnosis of cirrhosis
  • No evidence of hepatocellular carcinoma (HCC) by ultrasound
  • Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)

Exclusion criteria

Exclusion criteria:

  • Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
  • Use of any investigational drugs within 30 days prior to study enrollment
  • Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
  • Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
  • Clinically significant ocular examination findings
  • Pre-existing significant psychiatric condition(s)
  • Clinical diagnosis of active or recent substance abuse
  • Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    PegIFN-2b + RBV+ boceprevir

    Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).

    Drug: boceprevir · Biological: PegIFN-2b · Drug: RBV

Interventions

  • Drugboceprevir

    Also known as: SCH 503034

  • BiologicalPegIFN-2b

    Also known as: Peginterferon alfa-2b, PegIntron, SCH 054031

  • DrugRBV

    Also known as: Ribavirin, Rebetol

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

    Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.

    Time frame: Week 72 (24 weeks after end of treatment)

  2. Percentage of Participants With One or More Adverse Events

    Adverse events were monitored during the Lead-in and Treatment Periods

    Time frame: Up to 48 weeks (Lead-in and Treatment Periods)

  3. Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication

    Adverse events were monitored during the Lead-in and Treatment Periods

    Time frame: Up to 48 weeks (Lead-in and Treatment Periods)

07

Results

Posted Nov 21, 2016

Participant flow

Lead-in: Day 0 to Week 4
Participant flow — Lead-in: Day 0 to Week 4
MilestoneOverall Participants
Started58
Completed58
Not completed0
Treatment / Follow-up: Week 4 to Week 72
Participant flow — Treatment / Follow-up: Week 4 to Week 72
MilestoneOverall Participants
Started58
Treated in treatment period54
Completed23
Not completed35
Withdrew: Withdrawal by subject4
Withdrew: Adverse event5
Withdrew: No information available2
Withdrew: Lack of efficacy20
Withdrew: No boceprevir during treatment period4

Outcome measures

PrimaryPercentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (\<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.

Time frame:
Week 72 (24 weeks after end of treatment)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
Percentage of participantsOverall Participants
Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)35.2 (22.7 to 49.4)
PrimaryPercentage of Participants With One or More Adverse Events

Adverse events were monitored during the Lead-in and Treatment Periods

Time frame:
Up to 48 weeks (Lead-in and Treatment Periods)
Reported as:
Number · Percentage of participants
Percentage of Participants With One or More Adverse Events
Percentage of participantsOverall Participants
Percentage of Participants With One or More Adverse Events98.1
PrimaryPercentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication

Adverse events were monitored during the Lead-in and Treatment Periods

Time frame:
Up to 48 weeks (Lead-in and Treatment Periods)
Reported as:
Number · Percentage of participants
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
Percentage of participantsOverall Participants
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication9.3

Adverse events

Collected over Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Participants: Lead-in, Treatment and Follow-up—10/58 (17.2%)56/58 (96.6%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventOverall Participants: Lead-in, Treatment and Follow-up
AnaemiaBlood and lymphatic system disorders4/58
Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/58
VomitingGastrointestinal disorders2/58
PyrexiaGeneral disorders2/58
PneumoniaInfections and infestations2/58
NauseaGastrointestinal disorders1/58
AstheniaGeneral disorders1/58
Chest painGeneral disorders1/58
HyperpyrexiaGeneral disorders1/58
Parathyroid feverInfections and infestations1/58
Most frequent other events
Showing 10 of 36
Most frequent other events
EventOverall Participants: Lead-in, Treatment and Follow-up
AnaemiaBlood and lymphatic system disorders44/58
AstheniaGeneral disorders35/58
NeutropeniaBlood and lymphatic system disorders16/58
CoughRespiratory, thoracic and mediastinal disorders15/58
PyrexiaGeneral disorders15/58
DysgeusiaNervous system disorders14/58
NauseaGastrointestinal disorders12/58
Decreased appetiteMetabolism and nutrition disorders12/58
Adverse drug reactionGeneral disorders11/58
DyspnoeaRespiratory, thoracic and mediastinal disorders7/58

Baseline characteristics

All participants who received PegIFN-2b + RBV during the Lead-in Period

Age, Continuous
Age, Continuous(Years)Overall Participants
Mean59.3 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female19
Male39
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01756079
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 24, 2012
Start date
Feb 6, 2013
Primary completion
Nov 17, 2015
Completion
Nov 17, 2015
Results posted
Nov 21, 2016
Last update
Sep 5, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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