Hepatitis C, ChronicPhase 2NCT00704405

Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

A Phase 2 study testing Vaniprevir, Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) 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 test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Vaniprevir, Pegylated Interferon (Peg-IFN) and Ribavirin (RBV)
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: 285 participants
Where: No sites listed yet
Study dates: 27 Mar 2009to 10 Sep 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has chronic HCV genotype 1 infection
Is treatment-experienced
For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Who cannot join

Has not tolerated previous course peg-IFN and RBV
Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
Consumes excessive amounts of alcohol
Has a history of drug or alcohol abuse
If female, participant is pregnant or breastfeeding
Has been in a clinical trail with an investigational drug in the last 30 days
Has used IFN/Peg-IFN and RBV in the last 3 months

About this study

Official title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Conditions: Hepatitis C, Chronic
Being tested: Vaniprevir, Pegylated Interferon (Peg-IFN), Ribavirin (RBV), Placebo (PBO)
Keywords: hepatitis C
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

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

VaniprevirDrug
Also called MK-7009
Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.
Pegylated Interferon (Peg-IFN)Drug
Also called PEGASYS™
Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks
Ribavirin (RBV)Drug
Also called COPEGUS™
Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg.
Placebo (PBO)Drug
Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.

Study groups in NCT00704405
Study group	Role	What they receive
24-wk Vaniprevir 600 mg + Peg-IFN/RBV	Experimental	Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (Peg-IFN); Drug: Ribavirin (RBV)
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV	Experimental	Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (Peg-IFN); Drug: Ribavirin (RBV); Drug: Placebo (PBO)
48-wk Vaniprevir 300 mg + Peg-IFN/RBV	Experimental	Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (Peg-IFN); Drug: Ribavirin (RBV)
48-wk Vaniprevir 600 mg + Peg-IFN/RBV	Experimental	Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. Receives: Drug: Vaniprevir; Drug: Pegylated Interferon (Peg-IFN); Drug: Ribavirin (RBV)
48-wk PBO + Peg-IFN/RBV	Placebo comparator	PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks. Receives: Drug: Pegylated Interferon (Peg-IFN); Drug: Ribavirin (RBV); Drug: Placebo (PBO)

What is being measured

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

Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.
Measured: Up to 72 weeks
Number of Participants Experiencing an Adverse Event (AE)
The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Measured: Up to 73 weeks
Number of Participants Discontinuing From Study Treatment Due to AEs
The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.
Measured: Up to 48 weeks

Secondary outcomes (3)

Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.
The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.
Measured: 72 weeks
Percentage of Participants Achieving cEVR
The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.
Measured: Up to Week 60
Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.
The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.
Measured: Week 48

Timeline

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

27 Mar 200910 Sep 2012

First posted24 Jun 2008 (estimated)
Study start27 Mar 2009
Primary completion26 Mar 2012
Study completion10 Sep 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 (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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704405
Sponsor's protocol ID: 7009-009
Other IDs: 2007_659
Status last verified: Sep 2018
First submitted: 23 Jun 2008
Last updated: 9 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

Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21.
PubMed 23439259
Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10.
PubMed 24120953

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 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, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT00704405
Acronym / sponsor ID: 7009-009
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Mar 2009 (actual)
Primary completion: 26 Mar 2012 (actual)
Study completion: 10 Sep 2012 (actual)
First posted: 24 Jun 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
24-wk Vaniprevir 600 mg + Peg-IFN/RBV	Experimental	Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV)Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.
24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV	Experimental	Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO)Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
48-wk Vaniprevir 300 mg + Peg-IFN/RBV	Experimental	Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV)Vaniprevir 300 mg (total daily dose, taken once daily [q.d.]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
48-wk Vaniprevir 600 mg + Peg-IFN/RBV	Experimental	Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV)Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
48-wk PBO + Peg-IFN/RBV	Placebo comparator	Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO)PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Has chronic HCV genotype 1 infection
Is treatment-experienced
For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Key exclusion criteria (8 listed)

Has not tolerated previous course peg-IFN and RBV
Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
Consumes excessive amounts of alcohol
Has a history of drug or alcohol abuse

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-7009Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.	Drug	24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Pegylated Interferon (Peg-IFN)Also: PEGASYS™Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks	Drug	24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Ribavirin (RBV)Also: COPEGUS™Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg.	Drug	24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV
Placebo (PBO)Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.	Drug	24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV

Primary outcome

Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.
Time frame: Up to 72 weeks
The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 73 weeks
The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
Number of Participants Discontinuing From Study Treatment Due to AEs
Time frame: Up to 48 weeks
The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.

3 secondary outcomes

Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.
Time frame: 72 weeks
Percentage of Participants Achieving cEVR
Time frame: Up to Week 60
Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.
Time frame: Week 48

Results and safety

Results posted to the registry on 29 Sep 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
24-wk Vaniprevir 600 mg + Peg-IFN/RBV	42	37
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV	44	40
48-wk Vaniprevir 300 mg + Peg-IFN/RBV	41	38
48-wk Vaniprevir 600 mg + Peg-IFN/RBV	42	38
48-wk PBO + Peg-IFN/RBV	42	37

Primary outcome: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.

Time frame: Up to 72 weeks. Number. Unit: Percentage of participants

Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 38	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n = 38	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 41	48-wk PBO + Peg-IFN/RBV n = 42
Value	71.1	84.2	78.0	19.0

24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV vs 48-wk PBO + Peg-IFN/RBV: Adjusted difference in percentage: 53.6 (95% CI 34.5 to 69.1), p <0.001, Miettinen and Nurminen method
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV vs 48-wk PBO + Peg-IFN/RBV: Adjusted difference in percentage: 64.4 (95% CI 45.2 to 78.3), p <0.001, Miettinen and Nurminen method
48-wk Vaniprevir 600 mg + Peg-IFN/RBV vs 48-wk PBO + Peg-IFN/RBV: Adjusted difference in percentage: 59.0 (95% CI 40.2 to 73.4), p <0.001, Miettinen and Nurminen

Population analysed: The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.

Primary outcome: Number of Participants Experiencing an Adverse Event (AE)

Time frame: Up to 73 weeks. Number. Unit: Number of participants

Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 40	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n = 42	48-wk Vaniprevir 300 mg + Peg-IFN/RBV n = 41	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 46	48-wk PBO + Peg-IFN/RBV n = 42
Value	38	42	40	46	41

Population analysed: The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.

Primary outcome: Number of Participants Discontinuing From Study Treatment Due to AEs

Time frame: Up to 48 weeks. Number. Unit: Number of participants

Measure	24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 40	24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV n = 42	48-wk Vaniprevir 300 mg + Peg-IFN/RBV n = 41	48-wk Vaniprevir 600 mg + Peg-IFN/RBV n = 46	48-wk PBO + Peg-IFN/RBV n = 42
Value	2	3	2	4	1

Population analysed: The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
24-wk Vaniprevir 600 mg + Peg-IFN/RBV	2 of 56 (3.6%)	53 of 56 (94.6%)	Not reported
24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV	5 of 56 (8.9%)	56 of 56 (100%)	Not reported
48-wk Vaniprevir 300 mg + Peg-IFN/RBV	6 of 56 (10.7%)	55 of 56 (98.2%)	Not reported
48-wk Vaniprevir 600 mg + Peg-IFN/RBV	9 of 61 (14.8%)	61 of 61 (100%)	Not reported
48-wk PBO + Peg-IFN/RBV	1 of 56 (1.8%)	55 of 56 (98.2%)	Not reported

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 23439259Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21.
Results publication: PubMed 24120953Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10.
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 (RBV) 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 3 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 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 SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (time frame: Up to 72 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 NCT00704405, 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 9 Oct 2018.