E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C infection |
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E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019751 |
E.1.2 | Term | Hepatitis C virus |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1) To evaluate the safety and tolerability of the MK-7009 300 mg b.i.d. treatment regimen and the MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by review of the accumulated safety data.
2) To evaluate the antiviral activity of the three MK-7009 600 mg b.i.d. treatment regimens as compared with 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]).
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E.2.2 | Secondary objectives of the trial |
To evaluate the antiviral activity of the MK-7009 300 mg b.i.d. treatment
regimen as compared with the control regimen, as assessed by the proportion of patients achieving SVR24.
To evaluate the antiviral activity of the MK-7009 300 mg b.i.d. treatment
regimen and the three MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by the proportion of patients achieving undetectable viral RNA at treatment Week 12 (complete Early Viral Response [cEVR]). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients (men and women 18 to 65 years of age) with chronic compensated genotype 1 HCV infection as defined by 1) positive serology for HCV with HCV RNA levels ≥4 ×105 IU/mL in peripheral blood at screening (within 60 days prior to the first dose of MK-7009); 2) evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA ≥6 months prior to the first dose of MK-7009; and 3) absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
Patient has received and tolerated coadministered peg-IFN (alfa-2a or -2b) and RBV, but failed to respond to at least one prior treatment course of at least 12 weeks duration. Patient's HCV treatment history (i.e., type of therapy and duration of therapy) and response to prior treatment (i.e., tolerability and HCV RNA data) should be available such that one of the following definitions are met: 1-Null Response: <2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+1 week); 2-Partial Response: ≥2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+1 week), with detectable HCV RNA at treatment Week 24; 3-Breakthrough: Detectable HCV RNA during treatment after initially achieving undetectable HCV RNA; 4-Relapse: Detectable HCV RNA after completion of 48 weeks or more of treatment in patients who achieved undetectable HCV RNA and maintained undetectable HCV RNA throughout the remainder of the treatment period.
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E.4 | Principal exclusion criteria |
Patient has non-genotype 1 HCV infection, including mixed genotype and has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
Patient was previously unable to complete 12 weeks of peg-IFN- or RBV-containing regimen due to intolerance of peg-IFN or RBV.
In the opinion of the investigator, the patient is unlikely to tolerate at least 24 weeks of continuous therapy with peg-IFN and RBV.
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E.5 End points |
E.5.1 | Primary end point(s) |
the antiviral activity of the three MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by the proportion of patients achieving undetectable viral RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]).
Safety and tolerability of the MK-7009 300 mg b.i.d. treatment regimen and the three MK-7009 600 mg b.i.d. treatment regimens as compared with placebo in combination with 48 weeks of peg-IFN and RBV, as assessed by review of the accumulated safety data.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Proportion of non-cirrhotic patient cohort achieving SVR24, for comparison of MK-7009 300 mg b.i.d. treatment regimen
with control regimen.
Proportion of non-cirrhotic patient cohort achieving complete EVR at Week 12, for comparison of the combined three arms of
MK-7009 600 mg b.i.d. treatment regimen with control regimen, and comparison of MK-7009 300 mg b.i.d. treatment regimen
with control regimen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |