Hepatitis C, ChronicPhase 3NCT01945294

Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)

A Phase 3 study testing Boceprevir, Peg-interferon alfa-2b and Ribavirin 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

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC)… 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, Peg-interferon alfa-2b and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: No sites listed yet
Study dates: 10 Oct 2013to 4 Nov 2015
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

weigh ≥ 40 kg and ≤ 125 kg
have CHC genotype 1 infection
has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
must agree that the participant and the participant's partner will each 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 medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Who cannot join

participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years

Show all 12Show fewer

has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
has pre-existing psychiatric condition(s)
has a clinical diagnosis of substance abuse
has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction
is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)

About this study

Official title: A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia

Conditions: Hepatitis C, Chronic
Being tested: Boceprevir, Peg-interferon alfa-2b, Ribavirin
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.

BoceprevirDrug
Also called MK-3034
800 mg three times daily orally
Peg-interferon alfa-2bBiological
Also called PegIntron
1.5 mcg/kg weekly subcutaneously
RibavirinDrug
Also called Rebetol
800-1400 mg twice-daily divided orally based on body weight

Study groups in NCT01945294
Study group	Role	What they receive
Arm 1: 16-week Treatment Arm	Experimental	All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28). Receives: Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin
Arm 2: 28-week Treatment Arm	Experimental	All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40). Receives: Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin
Arm 3: 48-week Treatment Arm	Experimental	All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). Receives: Drug: Boceprevir; Biological: Peg-interferon alfa-2b; Drug: Ribavirin

What is being measured

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

Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Measured: Follow-up Week (FW) 12 (up to 40 weeks)

Secondary outcomes (7)

Percentage of Participants With Undetectable HCV RNA Across Treatment
The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Measured: TW4, TW8, and TW12
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Measured: TW4, TW8, and TW12
Percentage of Participants With Relapse
The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Measured: From EOT to FW12 (up to 12 weeks)
Percentage of Participants With Neutropenia
The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.
Measured: Up to 60 weeks
Percentage of Participants With Anemia
The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.
Measured: Up to 60 weeks
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.
Measured: From TW1 through TW48
Percentage of Participants With Treatment-Related Serious AEs (SAEs)
A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.
Measured: Up to 60 weeks

Timeline

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

10 Oct 20134 Nov 2015

First posted18 Sep 2013 (estimated)
Study start10 Oct 2013
Primary completion5 Aug 2015
Study completion4 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 C, ChronicStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01945294
Sponsor's protocol ID: 3034-107
Status last verified: Jun 2018
First submitted: 13 Sep 2013
Last updated: 12 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia
ClinicalTrials.gov ID: NCT01945294
Acronym / sponsor ID: 3034-107
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Oct 2013 (actual)
Primary completion: 5 Aug 2015 (actual)
Study completion: 4 Nov 2015 (actual)
First posted: 18 Sep 2013 (estimated)
Results: Posted 23 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm 1: 16-week Treatment Arm	Experimental	Drug: Boceprevir, Biological: Peg-interferon alfa-2b, Drug: RibavirinAll screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
Arm 2: 28-week Treatment Arm	Experimental	Drug: Boceprevir, Biological: Peg-interferon alfa-2b, Drug: RibavirinAll screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
Arm 3: 48-week Treatment Arm	Experimental	Drug: Boceprevir, Biological: Peg-interferon alfa-2b, Drug: RibavirinAll screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).

Who may qualify

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

Key inclusion criteria (4 listed)

weigh ≥ 40 kg and ≤ 125 kg
have CHC genotype 1 infection
has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
must agree that the participant and the participant's partner will each 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 medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)

Key exclusion criteria (12 listed)

participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

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: MK-3034800 mg three times daily orally	Drug	Arm 1: 16-week Treatment Arm, Arm 2: 28-week Treatment Arm, Arm 3: 48-week Treatment Arm
Peg-interferon alfa-2bAlso: PegIntron1.5 mcg/kg weekly subcutaneously	Biological	Arm 1: 16-week Treatment Arm, Arm 2: 28-week Treatment Arm, Arm 3: 48-week Treatment Arm
RibavirinAlso: Rebetol800-1400 mg twice-daily divided orally based on body weight	Drug	Arm 1: 16-week Treatment Arm, Arm 2: 28-week Treatment Arm, Arm 3: 48-week Treatment Arm

Primary outcome

Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
Time frame: Follow-up Week (FW) 12 (up to 40 weeks)
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.

7 secondary outcomes

Percentage of Participants With Undetectable HCV RNA Across Treatment
Time frame: TW4, TW8, and TW12
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
Time frame: TW4, TW8, and TW12
Percentage of Participants With Relapse
Time frame: From EOT to FW12 (up to 12 weeks)
Percentage of Participants With Neutropenia
Time frame: Up to 60 weeks
Percentage of Participants With Anemia
Time frame: Up to 60 weeks
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
Time frame: From TW1 through TW48
Percentage of Participants With Treatment-Related Serious AEs (SAEs)
Time frame: Up to 60 weeks

Results and safety

Results posted to the registry on 23 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
All Treated Participants	257	236
Arm 1: 16-week Treatment Arm	0	0
Arm 2: 28-week Treatment Arm	0	0
Arm 3: 48-week Treatment Arm	0	0

Primary outcome: Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]

Time frame: Follow-up Week (FW) 12 (up to 40 weeks). Number. Unit: Percentage of Participants

Measure	Arm 1: 16-week Treatment Arm n = 102	Arm 2: 28-week Treatment Arm n = 105	Arm 3: 48-week Treatment Arm n = 0
Value	70.6	81.9	–

Arm 1: 16-week Treatment Arm vs Arm 2: 28-week Treatment Arm: Difference in SVR12 percentage: -11.4 (95% CI -23.2 to 0.4)

Population analysed: Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 60 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: 16-week Treatment Arm	9 of 102 (8.8%)	96 of 102 (94.1%)	Not reported
Arm 2: 28-week Treatment Arm	6 of 105 (5.7%)	98 of 105 (93.3%)	Not reported
Arm 3: 48-week Treatment Arm	4 of 50 (8%)	46 of 50 (92%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

Related trials for Hepatitis C, Chronic

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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 3 study testing Boceprevir, Peg-interferon alfa-2b and Ribavirin 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 4 inclusion and 12 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 12 Jul 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 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 23 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 With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm] (time frame: Follow-up Week (FW) 12 (up to 40 weeks)). 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 NCT01945294.

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 12 Jul 2018.