Chronic Genotype 1 Hepatitis C Virus InfectionPhase 2NCT00895882
Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)
A Phase 2 study testing vaniprevir (MK7009), Comparator: vaniprevir (MK7009) and Comparator: Pegylated Interferon (peg-IFN) alfa-2a in people with Chronic Genotype 1 Hepatitis C Virus Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Genotype 1 Hepatitis C Virus Infection
- What is being tested?
- vaniprevir (MK7009), Comparator: vaniprevir (MK7009) and Comparator: Pegylated Interferon (peg-IFN) alfa-2a
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has chronic genotype 1 HCV infection
- Patient has had a liver biopsy without evidence of cirrhosis
- Patient has had an eye exam prior to the start of study
- Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study
Who cannot join
- Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
- Female patient is pregnant or breastfeeding
- Patient has chronic hepatitis not caused by HCV
- Patient has evidence of cirrhosis of the liver
- Patient has HIV
- Patient has active hepatitis B infection
- Patient has non-genotype 1 HCV infection
- Patient consumes excessive amounts of alcohol
About this study
Official title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection
This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.
- Being tested
- vaniprevir (MK7009), Comparator: vaniprevir (MK7009), Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Comparator: Ribavirin, Comparator: Placebo to vaniprevir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaniprevir (MK7009)Drug
vaniprevir 300 mg soft gel capsules twice daily.
Comparator: vaniprevir (MK7009)Drug
vaniprevir 600 mg soft gel capsules twice daily.
Comparator: Pegylated Interferon (peg-IFN) alfa-2aDrug
Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly
Comparator: RibavirinDrug
Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
Comparator: Placebo to vaniprevirDrug
Placebo to vaniprevir soft gel capsules twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks Receives: Drug: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir |
| 2 | Experimental | vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks Receives: Drug: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin |
| 3 | Experimental | vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks Receives: Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir |
| 4 | Experimental | vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks Receives: Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin |
| 5 | Experimental | vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks Receives: Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin |
| 6 | Placebo comparator | Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks Receives: Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
Measured: 24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data
Measured: 72 Weeks
Secondary outcomes (1)
1) Proportion of patients achieving SVR24 in Treatment Regimen 5
Measured: 1) 24 weeks after end of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startNov 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Genotype 1 Hepatitis C Virus InfectionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895882
- Sponsor's protocol ID
- 7009-019
- Other IDs
- 2009_586
- Status last verified
- Oct 2015
- First submitted
- 6 May 2009
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. 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, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00895882
- Acronym / sponsor ID
- 7009-019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vaniprevir (MK7009), Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirin, Drug: Comparator: Placebo to vaniprevirvaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks |
| 2 | Experimental | Drug: vaniprevir (MK7009), Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirinvaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks |
| 3 | Experimental | Drug: Comparator: vaniprevir (MK7009), Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirin, Drug: Comparator: Placebo to vaniprevirvaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks |
| 4 | Experimental | Drug: Comparator: vaniprevir (MK7009), Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirinvaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks |
| 5 | Experimental | Drug: Comparator: vaniprevir (MK7009), Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirinvaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks |
| 6 | Placebo comparator | Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a, Drug: Comparator: Ribavirin, Drug: Comparator: Placebo to vaniprevirPlacebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has chronic genotype 1 HCV infection
- Patient has had a liver biopsy without evidence of cirrhosis
- Patient has had an eye exam prior to the start of study
- Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study
Key exclusion criteria (8 listed)
- Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
- Female patient is pregnant or breastfeeding
- Patient has chronic hepatitis not caused by HCV
- Patient has evidence of cirrhosis of the liver
- Patient has HIV
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 |
|---|---|---|
| vaniprevir (MK7009)vaniprevir 300 mg soft gel capsules twice daily. | Drug | 1, 2 |
| Comparator: vaniprevir (MK7009)vaniprevir 600 mg soft gel capsules twice daily. | Drug | 3, 4, 5 |
| Comparator: Pegylated Interferon (peg-IFN) alfa-2aPeg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: RibavirinRibavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily. | Drug | 1, 2, 3, 4, 5, 6 |
| Comparator: Placebo to vaniprevirPlacebo to vaniprevir soft gel capsules twice daily. | Drug | 1, 3, 6 |
Primary outcome
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4
Time frame: 24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data
Time frame: 72 Weeks
1 secondary outcome
1) Proportion of patients achieving SVR24 in Treatment Regimen 5
Time frame: 1) 24 weeks after end of study therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vaniprevir (MK7009), Comparator: vaniprevir (MK7009) and Comparator: Pegylated Interferon (peg-IFN) alfa-2a in people with Chronic Genotype 1 Hepatitis C Virus Infection, 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 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: withdrawn, as of the sponsor's last update on 22 Oct 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4 (time frame: 24 weeks after end of study therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2015.