A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Infectio

• Conditions: Chronic hepatitis C infection; MedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virus

• Registration Number: EUCTR2008-000150-12-LT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-01
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients (men and women 18 to 65 years of age) with chronic compensated genotype 1 HCV infection as defined by 1) positive serology for HCV with HCV RNA levels =4 ×105 IU/mL in peripheral blood at screening (within 60 days prior to the first dose of MK-7009); 2) evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to the first dose of MK-7009; and 3) absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
Patient has received and tolerated coadministered peg-IFN (alfa-2a or -2b) and RBV, but failed to respond to at least one prior treatment course of at least 12 weeks duration. Patient's HCV treatment history (i.e., type of therapy and duration of therapy) and response to prior treatment (i.e., tolerability and HCV RNA data) should be available such that one of the following definitions are met: 1-Null Response: <2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+1 week); 2-Partial Response: =2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+1 week), with detectable HCV RNA at treatment Week 24; 3-Breakthrough: Detectable HCV RNA during treatment after initially achieving undetectable HCV RNA; 4-Relapse: Detectable HCV RNA after completion of 48 weeks or more of treatment in patients who achieved undetectable HCV RNA and maintained undetectable HCV RNA throughout the remainder of the treatment period.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has non-genotype 1 HCV infection, including mixed genotype and has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.

Patient was previously unable to complete 12 weeks of peg-IFN- or RBV-containing regimen due to intolerance of peg-IFN or RBV.
In the opinion of the investigator, the patient is unlikely to tolerate at least 24 weeks of continuous therapy with peg-IFN and RBV.

Study & Design

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