Hepatitis CPhase 4NCT01756079

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 study testing boceprevir, PegIFN-2b and RBV in people with Hepatitis C, 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hepatitis C
What is being tested?: boceprevir, PegIFN-2b and RBV
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: No sites listed yet
Study dates: 6 Feb 2013to 17 Nov 2015
Phase: Phase 4
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

About this study

Official title: A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)

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.

Conditions: Hepatitis C
Being tested: boceprevir, PegIFN-2b, RBV
Medical subject headings: Hepatitis C

What participants receive

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

boceprevirDrug
Also called SCH 503034
PegIFN-2bBiological
Also called Peginterferon alfa-2b, PegIntron, SCH 054031
RBVDrug
Also called Ribavirin, Rebetol

Study groups in NCT01756079
Study group	Role	What they receive
PegIFN-2b + RBV+ boceprevir	Experimental	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). Receives: Drug: boceprevir; Biological: PegIFN-2b; Drug: RBV

What is being measured

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

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.
Measured: Week 72 (24 weeks after end of treatment)
Percentage of Participants With One or More Adverse Events
Adverse events were monitored during the Lead-in and Treatment Periods
Measured: Up to 48 weeks (Lead-in and Treatment Periods)
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
Adverse events were monitored during the Lead-in and Treatment Periods
Measured: Up to 48 weeks (Lead-in and Treatment Periods)

Timeline

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

6 Feb 201317 Nov 2015

First posted24 Dec 2012 (estimated)
Study start6 Feb 2013
Primary completion17 Nov 2015
Study completion17 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT01756079
Sponsor's protocol ID: 3034-105
Other IDs: 2012-002772-13
Status last verified: Aug 2018
First submitted: 19 Dec 2012
Last updated: 5 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)
ClinicalTrials.gov ID: NCT01756079
Acronym / sponsor ID: 3034-105
Conditions: Hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Feb 2013 (actual)
Primary completion: 17 Nov 2015 (actual)
Study completion: 17 Nov 2015 (actual)
First posted: 24 Dec 2012 (estimated)
Results: Posted 21 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PegIFN-2b + RBV+ boceprevir	Experimental	Drug: boceprevir, Biological: PegIFN-2b, Drug: RBVParticipants 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
boceprevirAlso: SCH 503034	Drug	PegIFN-2b + RBV+ boceprevir
PegIFN-2bAlso: Peginterferon alfa-2b, PegIntron, SCH 054031	Biological	PegIFN-2b + RBV+ boceprevir
RBVAlso: Ribavirin, Rebetol	Drug	PegIFN-2b + RBV+ boceprevir

Primary outcome

Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
Time frame: Week 72 (24 weeks after end of treatment)
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.
Percentage of Participants With One or More Adverse Events
Time frame: Up to 48 weeks (Lead-in and Treatment Periods)
Adverse events were monitored during the Lead-in and Treatment Periods
Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
Time frame: Up to 48 weeks (Lead-in and Treatment Periods)
Adverse events were monitored during the Lead-in and Treatment Periods

Results and safety

Results posted to the registry on 21 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	58	58

Primary outcome: Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)

Time frame: Week 72 (24 weeks after end of treatment). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Overall Participants n = 54
Value	35.2 (22.7 to 49.4)

Population analysed: The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.

Primary outcome: Percentage of Participants With One or More Adverse Events

Time frame: Up to 48 weeks (Lead-in and Treatment Periods). Number. Unit: Percentage of participants

Measure	Overall Participants n = 54
Value	98.1

Population analysed: Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period

Primary outcome: Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication

Time frame: Up to 48 weeks (Lead-in and Treatment Periods). Number. Unit: Percentage of participants

Measure	Overall Participants n = 54
Value	9.3

Population analysed: Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period

Adverse events

Time frame: Up to 72 weeks (including Lead-in, Treatment, and Follow-up Periods). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Participants: Lead-in, Treatment and Follow-up	10 of 58 (17.2%)	56 of 58 (96.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing boceprevir, PegIFN-2b and RBV in people with Hepatitis C, 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 6 inclusion and 8 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 5 Sep 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 21 Nov 2016). 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?

Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24) (time frame: Week 72 (24 weeks after end of treatment)). The study lists 3 primary outcomes in all. 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 NCT01756079.

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 5 Sep 2018.