Hepatitis C, ChronicPhase 3NCT01405937

Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)

A Phase 3 study testing vaniprevir, peg-IFN 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

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: vaniprevir, peg-IFN 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: 51 participants
Where: No sites listed yet
Study dates: 29 Aug 2011to 12 Mar 2013
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 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese participant diagnosed with compensated CHC GT 1
Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
No evidence of cirrhosis

Who cannot join

Co-infection with human immunodeficiency virus (HIV)
Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant

About this study

Official title: A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).

Conditions: Hepatitis C, Chronic
Being tested: vaniprevir, peg-IFN, 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.

vaniprevirDrug
Also called MK-7009
vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
peg-IFNBiological
Also called PegIntron®
peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks
ribavirinDrug
Also called REBETOL®
Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks

Study groups in NCT01405937
Study group	Role	What they receive
Vaniprevir 12 Week Arm	Experimental	Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV Receives: Drug: vaniprevir; Biological: peg-IFN; Drug: ribavirin
Vaniprevir 24 Week Arm	Experimental	Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV Receives: Drug: vaniprevir; Biological: peg-IFN; Drug: ribavirin

What is being measured

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

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: 24 weeks after 24 weeks of study therapy (up to 48 weeks)
Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
Percentage of Participants Who Discontinued Study Drug Due to an AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.
Measured: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)

Secondary outcomes (5)

Percentage of Participants Achieving SVR12
SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: 12 weeks after 24 weeks of study therapy (up to 36 weeks)
Percentage of Participants Achieving Rapid Virologic Response (RVR)
RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: At Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: At Week 12
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Measured: At Week 24
Mean Change From Baseline in HCV RNA (Log 10)
HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered "undetectable".
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

Timeline

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

29 Aug 201112 Mar 2013

First posted29 Jul 2011 (estimated)
Study start29 Aug 2011
Primary completion26 Feb 2013
Study completion12 Mar 2013

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.
Publications (2)Papers the sponsor has linked to this study.
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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405937
Sponsor's protocol ID: 7009-044
Status last verified: Sep 2018
First submitted: 28 Jul 2011
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Kumada H, Mochida S, Suzuki F, Chayama K, Karino Y, Nakamura K, Fujimoto G, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 (GT1b) infection: Phase 3 studies. J Gastroenterol Hepatol. 2016 Oct;31(10):1674-1683. doi: 10.1111/jgh.13328.
PubMed 26936417
Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.
PubMed 26947564

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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Concomitantly Administered With Peginterferon Alfa-2b and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection Who Relapsed After Previous Treatment
ClinicalTrials.gov ID: NCT01405937
Acronym / sponsor ID: 7009-044
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 29 Aug 2011 (actual)
Primary completion: 26 Feb 2013 (actual)
Study completion: 12 Mar 2013 (actual)
First posted: 29 Jul 2011 (estimated)
Results: Posted 13 Oct 2014

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: 2

Arm	Type	Receives
Vaniprevir 12 Week Arm	Experimental	Drug: vaniprevir, Biological: peg-IFN, Drug: ribavirinParticipants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
Vaniprevir 24 Week Arm	Experimental	Drug: vaniprevir, Biological: peg-IFN, Drug: ribavirinParticipants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Japanese participant diagnosed with compensated CHC GT 1
Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
No evidence of cirrhosis

Key exclusion criteria (4 listed)

Co-infection with human immunodeficiency virus (HIV)
Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant

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
vaniprevirAlso: MK-7009vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks	Drug	Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm
peg-IFNAlso: PegIntron®peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks	Biological	Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm
ribavirinAlso: REBETOL®Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks	Drug	Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
Time frame: 24 weeks after 24 weeks of study therapy (up to 48 weeks)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study
Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.

5 secondary outcomes

Percentage of Participants Achieving SVR12
Time frame: 12 weeks after 24 weeks of study therapy (up to 36 weeks)
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Time frame: At Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
Time frame: At Week 12
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
Time frame: At Week 24
Mean Change From Baseline in HCV RNA (Log 10)
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

Results and safety

Results posted to the registry on 13 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaniprevir 12 Week Arm	25	25
Vaniprevir 24 Week Arm	26	26

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)

Time frame: 24 weeks after 24 weeks of study therapy (up to 48 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 25	Vaniprevir 24 Week Arm n = 26
Value	92.0 (74.0 to 99.0)	96.2 (80.4 to 99.9)

Vaniprevir 12 Week Arm: p <0.001, exact test for binomial proportion
Vaniprevir 24 Week Arm: p <0.001, exact test for binomial proportion

Population analysed: Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.

Primary outcome: Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 25	Vaniprevir 24 Week Arm n = 26
With ≥1 specific AEs	88.0 (68.8 to 97.5)	84.6 (65.1 to 95.6)
anaemia	56.0 (34.9 to 75.6)	61.5 (40.6 to 79.8)
bilirubin increased	8.0 (1.0 to 26.0)	3.8 (0.1 to 19.6)
GI AEs	64.0 (42.5 to 82.0)	65.4 (44.3 to 82.8)
neutropenia	40.0 (21.1 to 61.3)	42.3 (23.4 to 63.1)

Population analysed: All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an AE

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks). Number. Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 25	Vaniprevir 24 Week Arm n = 26
Value	4.0	0.0

Population analysed: All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaniprevir 12 Week Arm	2 of 25 (8%)	24 of 25 (96%)	Not reported
Vaniprevir 24 Week Arm	3 of 26 (11.5%)	26 of 26 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26936417Kumada H, Mochida S, Suzuki F, Chayama K, Karino Y, Nakamura K, Fujimoto G, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 (GT1b) infection: Phase 3 studies. J Gastroenterol Hepatol. 2016 Oct;31(10):1674-1683. doi: 10.1111/jgh.13328.
Derived from this study: PubMed 26947564Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 4
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RecruitingObservational study
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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 vaniprevir, peg-IFN 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 4 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 18 Oct 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 13 Oct 2014). 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 Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) (time frame: 24 weeks after 24 weeks of study therapy (up to 48 weeks)). 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 NCT01405937, 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 18 Oct 2018.