Hepatitis CPhase 1NCT00518622

Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

A Phase 1 study testing Comparator: MK7009 in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Hepatitis C
What is being tested?: Comparator: MK7009
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: No sites listed yet
Study dates: Jul 2007to Sep 2008
Phase: Phase 1
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject is a man or a woman aged 18 to 55 years of age.
Subject has chronic Hepatitis C
Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Who cannot join

Patient has evidence of advanced liver disease.
Patient has human immunodeficiency virus (HIV)
Patient has Hepatitis B

About this study

Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

Conditions: Hepatitis C
Being tested: Comparator: MK7009, 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.

Comparator: MK7009Drug
Also called MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Comparator: PlaceboDrug
MK7009 Placebo

Study groups in NCT00518622
Study group	Role	What they receive
1	Experimental	25 mg b.i.d. MK7009 Receives: Drug: Comparator: MK7009
2	Experimental	75 mg b.i.d. MK7009 Receives: Drug: Comparator: MK7009
3	Experimental	250 mg b.i.d. MK7009 Receives: Drug: Comparator: MK7009
4	Experimental	500 mg b.i.d. MK7009 Receives: Drug: Comparator: MK7009
5	Experimental	700 mg b.i.d. MK7009 Receives: Drug: Comparator: MK7009
6	Experimental	125 mg q.d. MK7009 Receives: Drug: Comparator: MK7009
7	Experimental	600 mg q.d. MK7009 Receives: Drug: Comparator: MK7009
8	Experimental	Placebo Receives: Drug: Comparator: Placebo

What is being measured

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

Safety and Tolerability of MK7009
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Measured: 14 days after completion of study therapy
Antiviral Activity of MK7009
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Measured: Baseline and Day 8

Timeline

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

Jul 2007Sep 2008

First posted21 Aug 2007 (estimated)
Study startJul 2007
Primary completionSep 2008
Study completionSep 2008

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518622
Sponsor's protocol ID: 7009-004
Other IDs: 2007_517
Status last verified: Aug 2015
First submitted: 17 Aug 2007
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
PubMed 23747481

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
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
ClinicalTrials.gov ID: NCT00518622
Acronym / sponsor ID: 7009-004
Conditions: Hepatitis C
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 21 Aug 2007 (estimated)
Results: Posted 16 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
1	Experimental	Drug: Comparator: MK700925 mg b.i.d. MK7009
2	Experimental	Drug: Comparator: MK700975 mg b.i.d. MK7009
3	Experimental	Drug: Comparator: MK7009250 mg b.i.d. MK7009
4	Experimental	Drug: Comparator: MK7009500 mg b.i.d. MK7009
5	Experimental	Drug: Comparator: MK7009700 mg b.i.d. MK7009
6	Experimental	Drug: Comparator: MK7009125 mg q.d. MK7009
7	Experimental	Drug: Comparator: MK7009600 mg q.d. MK7009
8	Experimental	Drug: Comparator: PlaceboPlacebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Subject is a man or a woman aged 18 to 55 years of age.
Subject has chronic Hepatitis C
Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Key exclusion criteria (3 listed)

Patient has evidence of advanced liver disease.
Patient has human immunodeficiency virus (HIV)
Patient has Hepatitis B

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
Comparator: MK7009Also: MK7009Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.	Drug	1, 2, 3, 4, 5, 6, 7
Comparator: PlaceboMK7009 Placebo	Drug	8

Primary outcome

Safety and Tolerability of MK7009
Time frame: 14 days after completion of study therapy
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Antiviral Activity of MK7009
Time frame: Baseline and Day 8
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8

Results and safety

Results posted to the registry on 16 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 mg b.i.d. MK7009	3	3
75 mg b.i.d. MK7009	6	5
250 mg b.i.d. MK7009	6	5
500 mg b.i.d. MK7009	5	5
700 mg b.i.d. MK7009	6	6
125 mg q.d. MK7009	5	5
600 mg q.d. MK7009	4	4
Placebo	5	5

Primary outcome: Safety and Tolerability of MK7009

Time frame: 14 days after completion of study therapy. Number. Unit: Participants

Measure	25 mg b.i.d. MK7009 n = 3	75 mg b.i.d. MK7009 n = 6	250 mg b.i.d. MK7009 n = 6	500 mg b.i.d. MK7009 n = 5	700 mg b.i.d. MK7009 n = 6	125 mg q.d. MK7009 n = 5	600 mg q.d. MK7009 n = 4	Placebo n = 5
Value	2	3	6	4	2	5	1	3

Population analysed: All treated patients are included in the safety analysis.

Primary outcome: Antiviral Activity of MK7009

Time frame: Baseline and Day 8. Mean (Standard Deviation). Unit: Log10 IU/mL HCV RNA

Measure	25 mg b.i.d. MK7009 n = 3	75 mg b.i.d. MK7009 n = 5	250 mg b.i.d. MK7009 n = 6	500 mg b.i.d. MK7009 n = 5	700 mg b.i.d. MK7009 n = 6	125 mg q.d. MK7009 n = 5	600 mg q.d. MK7009 n = 4	Placebo n = 5
Value	-1.90 (0.40)	-2.54 (0.69)	-2.80 (0.96)	-3.27 (0.98)	-4.62 (0.39)	-1.82 (0.61)	-2.35 (0.21)	0.11 (0.18)

25 mg b.i.d. MK7009 vs Placebo: Mean Difference (Net): -2.01 (95% CI -2.87 to -1.14)
75 mg b.i.d. MK7009 vs Placebo: Mean Difference (Net): -2.64 (95% CI -3.49 to -1.80)
250 mg b.i.d. MK7009 vs Placebo: Mean Difference (Net): -2.90 (95% CI -3.90 to -1.90)

Population analysed: Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 mg b.i.d. MK7009	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
75 mg b.i.d. MK7009	0 of 6 (0%)	3 of 6 (50%)	Not reported
250 mg b.i.d. MK7009	0 of 6 (0%)	6 of 6 (100%)	Not reported
500 mg b.i.d. MK7009	0 of 5 (0%)	4 of 5 (80%)	Not reported
700 mg b.i.d. MK7009	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
125 mg q.d. MK7009	0 of 5 (0%)	5 of 5 (100%)	Not reported
600 mg q.d. MK7009	0 of 4 (0%)	1 of 4 (25%)	Not reported
Placebo	0 of 5 (0%)	3 of 5 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23747481Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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

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 1 study testing Comparator: MK7009 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 3 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 25 Aug 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 16 Sep 2009). 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?

Safety and Tolerability of MK7009 (time frame: 14 days after completion 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?

On the ClinicalTrials.gov record for NCT00518622, 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 25 Aug 2015.