A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infectio
- Conditions
- Chronic viral hepatitis CB182-B182 Chronic viral hepatitis C
- Registration Number
- PER-090-09
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Men and women 18 to 65 years of age (inclusive).
• The patient has a chronic infection, compensated for by HCV GT 1
• The patient has had a liver biopsy without evidence of cirrhosis. A liver biopsy performed before selection is acceptable if it was performed within 2 years of selection and the result was METAVIR from Stage FO to F3 (stage O to 3 fibrosis). If the previous liver biopsy was obtained outside the acceptable windows, a repeated biopsy should be performed, and the results should not show evidence of cirrhosis in order for the patient to be randomized in the study.
• The patient has the following laboratory values within 75 days prior to the first dose. Note: With the exception of the INR, patients may NOT undergo a new test if their laboratory results are outside the specified criteria. However, if for reasons other than the new test, more than one group of values is available during the selection period, the group closest to the entry into the study should be used for the final evaluation of eligibility. The results excluding the INR can be subjected to a new test at the facilities of the local and / or central laboratory to confirm the exclusions.
• The patient has had an eye exam before the start of the study therapy. As specified on the peg-IFN product label, patients with pre-existing ophthalmologic disorders (for example, diabetic or hypertensive retinopathy) should receive periodic ophthalmological examinations as directed, and any patient who develops ocular symptoms should undergo an examination. Immediate and complete eye.
• In the opinion of the researcher, the patient receiving maintenance therapy with methadone is in a stable regimen of methadone before the first dose of MK-7009.
• Potentially fertile female patients or male patients with potentially fertile female sexual partners agree to use two acceptable contraceptive methods throughout the treatment and after the end of the entire treatment, in accordance with the local product label of peg-IFN and RBV (for example, for an additional 6 months [US Product Insert] or an additional 7 months [Summary of EU Product Characteristics]). Acceptable contraceptive methods are: intrauterine device (IUD), spermicide diaphragm, contraceptive sponge, condom, vasectomy. Hormonal contraceptives (for example, birth control pills, transdermal patch, or injectables) are not acceptable contraceptive methods to be used in this study because it is unknown if these methods are affected by co-administration of MK-7009.
• The patient is not old enough to give his legal consent, is mentally or legally incapacitated, presents significant emotional problems at the time of the pre-study selection visit or is expected to have them during the conduct of the study or has a history of a clinically significant psychiatric disorder that, in the opinion of the researcher, would interfere with the study procedures.
• The patient received a 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 research therapies or vaccines for HCV.
• In the opinion of the researcher, the patient is not likely to tolerate a minimum of 24 weeks of continuous therapy with peg-IFN and RBV.
• The female patient is pregnant, breastfeeding, expects to conceive or donate eggs, or is potentially fertile and is not willing to commit to using two contraceptive methods during the entire treatment and after completing the entire treatment (see Criteria of Inclusion # 7). The male patient is thinking of getting pregnant or donating sperm, or has a potentially fertile female sexual partner and is not willing to commit to using two contraceptive methods throughout the treatment and after completing the entire treatment (see the Inclusion Criteria # 7).
• The patient has evidence or history of chronic hepatitis not caused by HCV, including, without limitation, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis and autoimmune hepatitis.
• The patient has a coinfection with the human immunodeficiency virus (HIV).
• The patient has a positive result for hepatitis B surface antigen or other evidence of active hepatitis B infection.
• The patient has an HCV infection from a different GT than GT 1, such as the mixed GT.
• The patient has a history of gastric bypass surgery, bowel resection or other disorder that, in the opinion of the researcher, may interfere with the absorption of the study drug.
• The patient has a history of stroke, recurrent seizures or major neurological disorder.
• The patient has a history of abnormalities or endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory or genitourinary abnormalities that are clinically significant.
• The patient has a history of neoplastic disease (such as hepatoma, leukemia, lymphoma, malignant melanoma) or myeloproliferative disease, regardless of the time elapsed since treatment.
• The patient has any other condition that is contraindicated for treatment with peg-IFN or RBV
• At the time of selection, the patient ingests excessive amounts of alcohol, which are defined as more than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to; beer [284 mL], wine [125 mL] or distilled spirits [25 mL]) per day and / or, in the opinion of the researcher, the patient is not willing to refrain from excessive alcohol consumption during their participation in the study (2 weeks before therapy until the end of the study).
• The patient is currently a regular user (including recreational use) of any illicit drug or has a recent history of drug abuse (including alcohol) that, in the opinion of the investigator, would interfere with the patient´s ability to comply with the protocol.
• Within 2 weeks prior to the first dose of the study and throughout the study, the patient requires
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The primary efficacy endpoint will be the proportion of patients reaching an SVR24, (an HCV RNA not detectable 24 weeks after the end of all study therapy), for the comparison of Treatment Regimes 1 to 4 with the control regime<br>Measure:Proportions of Patients With Virological Responses<br>Timepoints:The proportions of patients with virological responses will be estimated at Week 4, Week 12, Week 24, Week 48, and 12 and 24 weeks after the completion of all study therapy.<br>
- Secondary Outcome Measures
Name Time Method