Hepatitis CPhase 2NCT00880763
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
A Phase 2 study testing Vaniprevir, Pegylated Interferon (peg-IFN) and Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Vaniprevir, Pegylated Interferon (peg-IFN) and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2009to 23 Feb 2012
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has chronic genotype 1 Hepatitis C infection
Who cannot join
- Has not tolerated previous course of peg-IFN and ribavirin
- Has HIV
- Has Hepatitis B
- Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin
About this study
Official title: A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.
- Conditions
- Hepatitis C
- Being tested
- Vaniprevir, Pegylated Interferon (peg-IFN), Ribavirin, Comparator: Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaniprevirDrug
Also called MK7009
Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
Pegylated Interferon (peg-IFN)Drug
Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
RibavirinDrug
Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
Comparator: PlaceboDrug
Placebo to vaniprevir oral capsule twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Vaniprevir 200 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (peg-IFN); Drug: Ribavirin |
| Vaniprevir 600 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (peg-IFN); Drug: Ribavirin |
| Vaniprevir 1200 mg + peg-IFN + ribavirin | Experimental | Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (peg-IFN); Drug: Ribavirin |
| Placebo + peg-IFN + ribavirin | Placebo comparator | Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. Receives: Drug: Pegylated Interferon (peg-IFN); Drug: Ribavirin; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Rapid Viral Response
Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.
Measured: Week 4
Secondary outcomes (5)
Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Measured: Baseline and Week 4
Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Measured: Baseline and Week 4
Change From Baseline in HCV RNA in log10 at Week 4
Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
Measured: Baseline and Week 4
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 6 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study start20 Apr 2009
- Primary completion3 Jun 2010
- Study completion23 Feb 2012
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 (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880763
- Sponsor's protocol ID
- 7009-016
- Other IDs
- 2009_576
- Status last verified
- Sep 2018
- First submitted
- 10 Apr 2009
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13.
PubMed 25115901
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00880763
- Acronym / sponsor ID
- 7009-016
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2009 (actual)
- Primary completion
- 3 Jun 2010 (actual)
- Study completion
- 23 Feb 2012 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaniprevir 200 mg + peg-IFN + ribavirin | Experimental | Drug: Vaniprevir, Drug: Pegylated Interferon (peg-IFN), Drug: RibavirinParticipants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| Vaniprevir 600 mg + peg-IFN + ribavirin | Experimental | Drug: Vaniprevir, Drug: Pegylated Interferon (peg-IFN), Drug: RibavirinParticipants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| Vaniprevir 1200 mg + peg-IFN + ribavirin | Experimental | Drug: Vaniprevir, Drug: Pegylated Interferon (peg-IFN), Drug: RibavirinParticipants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
| Placebo + peg-IFN + ribavirin | Placebo comparator | Drug: Pegylated Interferon (peg-IFN), Drug: Ribavirin, Drug: Comparator: PlaceboParticipants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Has chronic genotype 1 Hepatitis C infection
Key exclusion criteria (4 listed)
- Has not tolerated previous course of peg-IFN and ribavirin
- Has HIV
- Has Hepatitis B
- Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin
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: MK7009Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days | Drug | Vaniprevir 1200 mg + peg-IFN + ribavirin, Vaniprevir 200 mg + peg-IFN + ribavirin, Vaniprevir 600 mg + peg-IFN + ribavirin |
| Pegylated Interferon (peg-IFN)Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks | Drug | Placebo + peg-IFN + ribavirin, Vaniprevir 1200 mg + peg-IFN + ribavirin, Vaniprevir 200 mg + peg-IFN + ribavirin, Vaniprevir 600 mg + peg-IFN + ribavirin |
| RibavirinOpen-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks | Drug | Placebo + peg-IFN + ribavirin, Vaniprevir 1200 mg + peg-IFN + ribavirin, Vaniprevir 200 mg + peg-IFN + ribavirin, Vaniprevir 600 mg + peg-IFN + ribavirin |
| Comparator: PlaceboPlacebo to vaniprevir oral capsule twice daily for 28 days | Drug | Placebo + peg-IFN + ribavirin |
Primary outcome
Percentage of Participants Achieving Rapid Viral Response
Time frame: Week 4
Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.
5 secondary outcomes
Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
Time frame: Baseline and Week 4
Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
Time frame: Baseline and Week 4
Change From Baseline in HCV RNA in log10 at Week 4
Time frame: Baseline and Week 4
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 6 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25115901Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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 2 study testing Vaniprevir, Pegylated Interferon (peg-IFN) and Ribavirin 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 1 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 9 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Sep 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 Rapid Viral Response (time frame: Week 4). 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 NCT00880763, which also lists 1 linked publication.
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 9 Oct 2018.