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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012000-10-BE

Enrollment

530

Registered

2009-05-26

Start date

2009-07-13

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C infection MedDRA version: 9.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus

Interventions

Product Name: MK-7009 Pharmaceutical Form: Capsule* Current Sponsor code: MK-7009 Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient (Men and women 18 to 65 years of age) has chronic genotype 1 HCV infection. 2. Patient has had a liver biopsy without evidence of cirrhosis. 3. Female patient who is of childbearing potential or male patient with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control throughout treatment, and after completing all treatment, in accordance with the local peg-IFN and RBV product labels. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patient had previous treatment with: a. Three or more doses of IFN, peg-IFN, and/or RBV. b. IFN, peg-IFN, and/or RBV and discontinued treatment due to intolerance to one or more of these therapies. c. Other antiviral or investigational therapies or vaccines for HCV. 2. Female patient is pregnant or breastfeeding. 3. Patient has evidence or history of chronic hepatitis not caused by HCV. 4. Patient has HIV. 5. Patient has active hepatitis B infection. 6. Patient has non-genotype 1 HCV infection. 7. Patient consumes excessive amounts of alcohol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the antiviral activity of the MK-7009 b.i.d. treatment regimens with 24 weeks of total duration (treatment regimens 1 to 4) as compared with placebo in combination with 48 weeks of peg-IFN and RBV (hereafter referred to as the control regimen), as assessed by the proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]). To evaluate the safety and tolerability of the MK-7009 treatment regimens as compared with the control regimen, as assessed by review of the accumulated safety data. ; Secondary Objective: To evaluate the antiviral activity of treatment regimen 5 (24 weeks of MK-7009 600 mg q.d.. in combination with peg-IFN and RBV) as compared with the control regimen, as assessed by the proportion of patients achieving SVR24 To evaluate the antiviral activity of the MK-7009 treatment regimens as assessed by the proportion of patients achieving undetectable HCV RNA 12 weeks after the end of all study therapy (Sustained Viral Response 12 [SVR12]), as compared with response at treatment Week 36 in the control regimen To evaluate the effectiveness of the MK-7009 treatment regimens as compared with the control regimen, as assessed by comparisons of the proportion of patients achieving undetectable HCV RNA: • 12 weeks after the end of all study therapy (SVR12). • At end of all study therapy (End of Treatment [EOT]). • At Week 4 (Rapid Viral Response [RVR]). • At Week 12 (complete Early Viral Response [cEVR]) ;Primary end point(s): The proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]).	—

Measure

Time frame

Main Objective: To evaluate the antiviral activity of the MK-7009 b.i.d. treatment regimens with 24 weeks of total duration (treatment regimens 1 to 4) as compared with placebo in combination with 48 weeks of peg-IFN and RBV (hereafter referred to as the control regimen), as assessed by the proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]). To evaluate the safety and tolerability of the MK-7009 treatment regimens as compared with the control regimen, as assessed by review of the accumulated safety data. ; Secondary Objective: To evaluate the antiviral activity of treatment regimen 5 (24 weeks of MK-7009 600 mg q.d.. in combination with peg-IFN and RBV) as compared with the control regimen, as assessed by the proportion of patients achieving SVR24 To evaluate the antiviral activity of the MK-7009 treatment regimens as assessed by the proportion of patients achieving undetectable HCV RNA 12 weeks after the end of all study therapy (Sustained Viral Response 12 [SVR12]), as compared with response at treatment Week 36 in the control regimen To evaluate the effectiveness of the MK-7009 treatment regimens as compared with the control regimen, as assessed by comparisons of the proportion of patients achieving undetectable HCV RNA: • 12 weeks after the end of all study therapy (SVR12). • At end of all study therapy (End of Treatment [EOT]). • At Week 4 (Rapid Viral Response [RVR]). • At Week 12 (complete Early Viral Response [cEVR]) ;Primary end point(s): The proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]).

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Countries

Austria, Belgium, Germany, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026