A Phase II Open Label Study of MK-7009 Administered Concomitantlywith Pegylated Interferon Alfa-2a and Ribavirin toPatients with Chronic Hepatitis C Infection After Participation inOther MK-7009 Clinical Trials

• Conditions: Chronic Hepatitis C Virus Infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2009-013053-15-AT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-18
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified