Hepatitis C, ChronicPhase 2NCT01440595

Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

A Phase 2 study testing Grazoprevir, Peginterferon alfa-2b (Peg-IFN) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections. 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?: Grazoprevir, Peginterferon alfa-2b (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: 5 participants
Where: No sites listed yet
Study dates: 28 Nov 2011to 1 May 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body weight ≥ 88 lbs and ≤ 275 lbs
Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
No known cirrhosis
Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
Chest X-ray within the last 6 months
Eye exam within the last 6 months

Who cannot join

Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
Prior approved or investigational treatment for hepatitis C
Evidence of hepatocellular carcinoma
Diabetic and/or high blood pressure with clinically significant eye exam findings
Pre-existing psychiatric condition
Clinical diagnosis of abuse of certain substances within specified timeframes

Show all 12Show fewer

Known medical condition that could interfere with participation
Active or suspected cancer within the last 5 years
Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
Male who is planning to impregnate partner or donate sperm
Male with a pregnant female partner
Chronic hepatitis not caused by HCV

About this study

Official title: A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection

Conditions: Hepatitis C, Chronic
Being tested: Grazoprevir, Placebo to Grazoprevir, Peginterferon alfa-2b (Peg-IFN), Ribavirin (RBV)
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

GrazoprevirDrug
Also called MK-5172
Grazoprevir 100 mg tablets once daily for 12 weeks.
Placebo to GrazoprevirDrug
Placebo to Grazoprevir once daily for 12 weeks
Peginterferon alfa-2b (Peg-IFN)Drug
Also called PegIntron®, SCH 054031
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Ribavirin (RBV)Drug
Also called Rebetol®, SCH 018908
Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Study groups in NCT01440595
Study group	Role	What they receive
Grazoprevir 200 mg + Peg-IFN + RBV	Experimental	Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. Receives: Drug: Grazoprevir; Drug: Peginterferon alfa-2b (Peg-IFN); Drug: Ribavirin (RBV)
Grazoprevir 400 mg + Peg-IFN + RBV	Experimental	Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. Receives: Drug: Grazoprevir; Drug: Peginterferon alfa-2b (Peg-IFN); Drug: Ribavirin (RBV)
Placebo + Peg-IFN + RBV	Placebo comparator	Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks. Receives: Drug: Placebo to Grazoprevir; Drug: Peginterferon alfa-2b (Peg-IFN); Drug: Ribavirin (RBV)
Grazoprevir 800 mg + Peg-IFN + RBV	Experimental	Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks. Receives: Drug: Grazoprevir; Drug: Peginterferon alfa-2b (Peg-IFN); Drug: Ribavirin (RBV)

What is being measured

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

Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.
Measured: Week 12

Secondary outcomes (6)

Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Number of Participants Achieving Rapid Viral Response (RVR)
RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Week 4
Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Week 12
Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
Measured: Week 24

Timeline

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

28 Nov 20111 May 2012

First posted26 Sep 2011 (estimated)
Study start28 Nov 2011
Primary completion1 May 2012
Study completion1 May 2012

Why it stopped: Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01440595
Sponsor's protocol ID: 5172-012
Other IDs: 2011-003299-36
Status last verified: May 2024
First submitted: 22 Sep 2011
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT01440595
Acronym / sponsor ID: 5172-012
Conditions: Hepatitis C, Chronic
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.
Enrolment: 5 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 28 Nov 2011 (actual)
Primary completion: 1 May 2012 (actual)
Study completion: 1 May 2012 (actual)
First posted: 26 Sep 2011 (estimated)
Results: Posted 4 Mar 2016

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: 4

Arm	Type	Receives
Grazoprevir 200 mg + Peg-IFN + RBV	Experimental	Drug: Grazoprevir, Drug: Peginterferon alfa-2b (Peg-IFN), Drug: Ribavirin (RBV)Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.
Grazoprevir 400 mg + Peg-IFN + RBV	Experimental	Drug: Grazoprevir, Drug: Peginterferon alfa-2b (Peg-IFN), Drug: Ribavirin (RBV)Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
Placebo + Peg-IFN + RBV	Placebo comparator	Drug: Placebo to Grazoprevir, Drug: Peginterferon alfa-2b (Peg-IFN), Drug: Ribavirin (RBV)Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
Grazoprevir 800 mg + Peg-IFN + RBV	Experimental	Drug: Grazoprevir, Drug: Peginterferon alfa-2b (Peg-IFN), Drug: Ribavirin (RBV)Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Body weight ≥ 88 lbs and ≤ 275 lbs
Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
No known cirrhosis
Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
Chest X-ray within the last 6 months

Key exclusion criteria (12 listed)

Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
Prior approved or investigational treatment for hepatitis C
Evidence of hepatocellular carcinoma
Diabetic and/or high blood pressure with clinically significant eye exam findings
Pre-existing psychiatric condition

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
GrazoprevirAlso: MK-5172Grazoprevir 100 mg tablets once daily for 12 weeks.	Drug	Grazoprevir 200 mg + Peg-IFN + RBV, Grazoprevir 400 mg + Peg-IFN + RBV, Grazoprevir 800 mg + Peg-IFN + RBV
Placebo to GrazoprevirPlacebo to Grazoprevir once daily for 12 weeks	Drug	Placebo + Peg-IFN + RBV
Peginterferon alfa-2b (Peg-IFN)Also: PegIntron®, SCH 054031Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks	Drug	Grazoprevir 200 mg + Peg-IFN + RBV, Grazoprevir 400 mg + Peg-IFN + RBV, Grazoprevir 800 mg + Peg-IFN + RBV, Placebo + Peg-IFN + RBV
Ribavirin (RBV)Also: Rebetol®, SCH 018908Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks	Drug	Grazoprevir 200 mg + Peg-IFN + RBV, Grazoprevir 400 mg + Peg-IFN + RBV, Grazoprevir 800 mg + Peg-IFN + RBV, Placebo + Peg-IFN + RBV

Primary outcome

Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
Time frame: Week 12
cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.

6 secondary outcomes

Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
Time frame: Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
Number of Participants Achieving Rapid Viral Response (RVR)
Time frame: Week 4
Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
Time frame: Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
Time frame: Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
Time frame: Week 12
Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
Time frame: Week 24

Results and safety

Results posted to the registry on 4 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Grazoprevir 200 mg + Peg-IFN + RBV	1	0
Grazoprevir 400 mg + Peg-IFN + RBV	3	0
Placebo + Peg-IFN + RBV	1	0

Primary outcome: Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms

Time frame: Week 12

Population analysed: The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Grazoprevir 400 mg + Peg-IFN + RBV	0 of 2 (0%)	2 of 2 (100%)	Not reported
Placebo + Peg-IFN + RBV	0 of 1 (0%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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 Grazoprevir, Peginterferon alfa-2b (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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 May 2024. 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 4 Mar 2016). 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 Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms (time frame: Week 12). 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 NCT01440595.

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 May 2024.