A follow on study with MK7009 in combination with pegylated inteferon and ribavirin for Hepatitis C patients who participated in other MK7009 studies

Phase 1

• Conditions: Hepatitis C Virus; MedDRA version: 14.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2009-013053-15-GB
• Lead Sponsor: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-21
• Study Completion: 2013-05-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Primary Outcome Measures

Name	Time	Method
Main Objective: In patients who have persistent HCV infection after prior participation in a MK-7009 clinical trial: Evaluate the safety and tolerability of MK-7009 600 mg b.i.d. for 48 weeks when used in combination with peg-IFN alfa-2a and RBV.;Secondary Objective: In patients previously treated with placebo + peg-IFN + RBV in a MK-7009 clinical trial, evaluate the antiviral activity of MK-7009 600 mg b.i.d., defined as Sustained Viral Response (SVR24) as measured by undetectable HCV viral RNA at 24 weeks after completion of treatment with MK-7009 600 mg b.i.d., peg-IFN alfa-2a and RBV.;Primary end point(s): The primary efficacy parameter will be the proportion of patients achieving SVR24 (undetectable viral RNA 24 weeks after end of treatment), in patients previously treated with placebo + peg-IFN + RBV in a MK-7009 clinical trial.