Hepatitis C, ChronicPhase 2NCT00943761

A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

A Phase 2 study testing Vaniprevir 600 mg b.i.d., Vaniprevir 300 mg b.i.d. and Pegylated interferon 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

Search all trials

Trial summary

This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622… 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?: Vaniprevir 600 mg b.i.d., Vaniprevir 300 mg b.i.d. and Pegylated interferon
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: 23 Oct 2009to 29 May 2013
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has participated in a prior vaniprevir clinical trial
Participant agrees to use acceptable birth control method during treatment

Who cannot join

More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
Participant received any investigational therapy for HCV after participating in the prior study

About this study

Official title: A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

Conditions: Hepatitis C, Chronic
Being tested: Vaniprevir 600 mg b.i.d., Vaniprevir 300 mg b.i.d., Pegylated interferon, Ribavirin
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.

Vaniprevir 600 mg b.i.d.Drug
Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks
Vaniprevir 300 mg b.i.d.Drug
Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks
Pegylated interferonDrug
Also called PEGASYS™
Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks
RibavirinDrug
Also called COPEGUS™
Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks

Study groups in NCT00943761
Study group	Role	What they receive
Vaniprevir 300 mg b.i.d. + peg-IFN + RBV	Experimental	Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily. Receives: Drug: Vaniprevir 300 mg b.i.d.; Drug: Pegylated interferon; Drug: Ribavirin
Vaniprevir 600 mg b.i.d. + peg-IFN + RBV	Experimental	Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily. Receives: Drug: Vaniprevir 600 mg b.i.d.; Drug: Pegylated interferon; Drug: Ribavirin

What is being measured

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

Number of Participants Who Experienced 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 72 weeks
Number of Participants Who Experienced a Serious Adverse Event
Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
Measured: up to 72 weeks
Number of Participants Who Discontinued Study Treatment 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: 48 weeks
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.
Measured: 72 weeks

Timeline

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

23 Oct 200929 May 2013

First posted22 Jul 2009 (estimated)
Study start23 Oct 2009
Primary completion29 May 2013
Study completion29 May 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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00943761
Sponsor's protocol ID: 7009-028
Other IDs: 2009_615, 2009-013053-15, 2009
Status last verified: Jan 2021
First submitted: 21 Jul 2009
Last updated: 8 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials
ClinicalTrials.gov ID: NCT00943761
Acronym / sponsor ID: 7009-028
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 23 Oct 2009 (actual)
Primary completion: 29 May 2013 (actual)
Study completion: 29 May 2013 (actual)
First posted: 22 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vaniprevir 300 mg b.i.d. + peg-IFN + RBV	Experimental	Drug: Vaniprevir 300 mg b.i.d., Drug: Pegylated interferon, Drug: RibavirinParticipants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
Vaniprevir 600 mg b.i.d. + peg-IFN + RBV	Experimental	Drug: Vaniprevir 600 mg b.i.d., Drug: Pegylated interferon, Drug: RibavirinParticipants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

Who may qualify

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

Key inclusion criteria (2 listed)

Participant has participated in a prior vaniprevir clinical trial
Participant agrees to use acceptable birth control method during treatment

Key exclusion criteria (3 listed)

More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
Participant received any investigational therapy for HCV after participating in the prior study

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 600 mg b.i.d.Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks	Drug	Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
Vaniprevir 300 mg b.i.d.Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks	Drug	Vaniprevir 300 mg b.i.d. + peg-IFN + RBV
Pegylated interferonAlso: PEGASYS™Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks	Drug	Vaniprevir 300 mg b.i.d. + peg-IFN + RBV, Vaniprevir 600 mg b.i.d. + peg-IFN + RBV
RibavirinAlso: COPEGUS™Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (<75 kg or ≥75 kg, respectively), for 48 weeks	Drug	Vaniprevir 300 mg b.i.d. + peg-IFN + RBV, Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

Primary outcome

Number of Participants Who Experienced an Adverse Event
Time frame: up to 72 weeks
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.
Number of Participants Who Experienced a Serious Adverse Event
Time frame: up to 72 weeks
Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
Time frame: 48 weeks
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.
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
Time frame: 72 weeks
SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.

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
Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV	21	17
Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV	24	23

Primary outcome: Number of Participants Who Experienced an Adverse Event

Time frame: up to 72 weeks. Number. Unit: Participants

Measure	Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV n = 21	Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV n = 24
Value	21	23

Population analysed: All participants as treated population consists of all participants who received at least one dose of study treatment.

Primary outcome: Number of Participants Who Experienced a Serious Adverse Event

Time frame: up to 72 weeks. Number. Unit: Participants

Measure	Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV n = 21	Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV n = 24
Value	4	1

Population analysed: All participants as treated population consists of all participants who received at least one dose of study treatment.

Primary outcome: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

Time frame: 48 weeks. Number. Unit: Participants

Measure	Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV n = 21	Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV n = 24
Value	2	1

Population analysed: All participants as treated population consists of all participants who received at least one dose of study treatment.

Primary outcome: Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)

Time frame: 72 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV n = 18	Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV n = 17
Value	66.7 (41.0 to 86.7)	70.6 (44.0 to 89.7)

Population analysed: Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive \>=1 dose of study drug, lack of any post-allocation endpoint data subsequent to \>=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study

Adverse events

Time frame: up to 72 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaniprevir 300 mg Bid + Peg-IFN + RBV	4 of 21 (19%)	21 of 21 (100%)	Not reported
Vaniprevir 600 mg Bid + Peg-IFN + RBV	1 of 24 (4.2%)	23 of 24 (95.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

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

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 600 mg b.i.d., Vaniprevir 300 mg b.i.d. and Pegylated interferon 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 2 inclusion and 3 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 8 Feb 2021. 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 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?

Number of Participants Who Experienced an Adverse Event (time frame: up to 72 weeks). The study lists 4 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 NCT00943761.

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 8 Feb 2021.