A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

Not Applicable

Conditions: -B182 Chronic viral hepatitis C
Chronic viral hepatitis C
B182

Registration Number: PER-130-09

Lead Sponsor: MERCK & CO.INC.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• The patient has completed or discontinued participation in a suitable original MK-7009 protocol, and the SPONSOR has provided the study site with written confirmation that the patient can be invited to participate in the PN028.
• The patient has an HCV RNA value above the detection limit of the analysis in the selection period.
• The patient has adequate laboratory values within the period of 75 days before the first dose
• The patient has had an eye exam before the start of the study therapy according to the product label peg-IFN alfa-2a.
• Potentially fertile female patients or male patients with a potentially fertile female sexual partner agree to use two acceptable contraceptive methods throughout the treatment, and after completing the entire treatment, in accordance with the peg-IFN alpha product labels -2a and RBV (for example, for an additional 6 months [Product insert for the United States] or 7 months [Summary of Product Characteristics for the European Union]). Acceptable contraceptive methods are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Hormonal contraceptives (for example, birth control pills, transdermal patch or injectables) are unacceptable contraceptive methods in this study because it is not known whether these methods are affected by the co-administration of MK-7009.

Exclusion Criteria

• More than 6 months have passed since the SPONSOR informed the study site that the patient meets the requirements for inclusion in the PN028.
• The patient received research therapy for HCV infection during the period between completion or discontinuation of the original study and the start of treatment in PN028.
• The patient discontinued the administration of MK-7009 and / or peg-IFN and / or RBV in the original protocol due to a safety or tolerability problem.
• According to the opinion of the researcher, the patient will probably not tolerate 48 weeks of continuous therapy with MK-7009 600 mg twice daily, peg-IFN alpha-2a and RBV.
• The patient has a condition that is contraindicated for treatment with peg-IFN alpha-2a or RBV (see product insert for full list).
• At the time of selection, the patient consumes excessive amounts of alcohol, defined as more than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL], wine [125 mL] or distilled alcoholic beverages [25 mL] ) a day and / or at the discretion of the investigator, 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 habitual consumer (including recreational use) of illicit drugs or has a recent history of drug abuse (including alcohol), which, 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 or is expected to require any of the prohibited drugs indicated in the administrative file.
• The patient has had major surgery or donated 1 unit of blood (approximately 500 mL) within 30 days before the start of the study drug.
• The patient has a clinically significant abnormality in the ECG performed at the selection visit before the study.
• The patient has a laboratory condition or abnormality before the study, or a history of illness that, in the opinion of the investigator, could confuse the results of the study or represent additional risks for the patient if MK-7009, peg-IFN alfa- is administered. 2nd and / or RBV.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.<br><br>Measure:Number of Participants Who Experienced an Adverse Event<br>Timepoints:up to 72 weeks<br>

Secondary Outcome Measures

Name	Time	Method

Related Trials