A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patients With Chronic Hepatitis C Infection.
- Conditions
- Chronic hepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virus
- Registration Number
- EUCTR2008-000149-72-CZ
- Lead Sponsor
- Merck & Co, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 85
1.Men and women 18 to 65 years of age (inclusive).
2.Chronic, compensated, genotype 1 HCV infection as defined by:
- Positive serology for HCV with HCV RNA levels =4 x 105 IU/mL in peripheral blood at screening (within 75 days prior to first dose of MK-7009).
- Evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to study drug administration.
- Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
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
1.Patient had previous treatment with:
- Three or more doses of IFN, peg-IFN, and/or ribavirin.
- IFN, peg-IFN, and/or ribavirin and discontinued treatment due to intolerance to one or more of these therapies.
- Other antiviral or investigational therapies or vaccines for HCV.
2.Patient has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. (Note: Patients with history of acute non-HCV-related hepatitis, which resolved >6 months before study entry, can be enrolled.)
3.Evidence of cirrhosis from prior liver biopsy or approved non-invasive imaging assessment within 3 years of study entry.
4.Patient has non-genotype 1 HCV infection, including mixed genotype.
5.Patient has any other condition that is contraindicated for treatment with peg-IFN or ribavirin, for example:
- Major, uncontrolled depressive illness
- Solid major organ transplant recipient (i.e., liver, renal, heart, or lung)
- Untreated hyperthyroidism
- Severe concurrent disease such as severe hypertension, congestive heart failure, significant coronary artery disease, poorly controlled diabetes mellitus, obstructive pulmonary disease, or chronic renal disease
- Known hypersensitivity to drugs used to treat HCV
- Other serious medical condition which could be exacerbated by peg-IFN and/or ribavirin, in the opinion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method