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

Merck & Co., Inc.0 个研究点目标入组 730 人开始时间: 2009年9月30日最近更新: 2012年4月3日

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•Patient has either completed or discontinued participation in an eligible MK-7009 parent protocol, and the SPONSOR has provided written confirmation to the study site that the patient may be offered participation in PN028.
•Patient has had an eye examination prior to the start of study therapy per the peg-IFN alfa-2a product label
•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 alfa-2a 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) yes
•F.1.3.1 Number of subjects for this age range

•Patient received investigational therapy for HCV infection between the time of completion or discontinuation of the parent study and initiation of treatment in PN028.
•Patient discontinued MK-7009 and/or peg-IFN and/or RBV in the parent protocol due to a safety or tolerability issue
•In the opinion of the investigator, the patient is unlikely to tolerate 48 weeks of continuous therapy with MK-7009 (300 or 600 mg b.i.d.), peg-IFN alfa-2a and RBV.
•Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering MK-7009, peg-IFN alfa-2a and/or RBV to the patient.

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