A Clinical Trial to Test Different Doses of MK-5172 administered with Other Hepatitis C Virus Treatments
- Conditions
- Chronic Hepatitis C Virus InfectionMedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003333-42-SE
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 87
In order to be eligible for participation in this trial, the subject must:
1. be =18 years of age on day of signing informed consent.
2. have a body weight >50 kg (111 lbs) and = 125 kg (275 lbs).
3. have chronic, compensated HCV GT 1a infection for Part A and GT1 (1a or 1b) for Part B as defined by:
• Positive serology for HCV with HCV RNA levels = 10,000 IU/mL in peripheral blood at screening, and
• Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
4. have had no evidence of cirrhosis and/or hepatocellular carcinoma. This can be confirmed either by liver biopsy or by non-invasive methods such as fibrotest or fibroscan in countries where biopsy is not the standard method of diagnosis.
• agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1) has a non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype.
2) is NOT treatment naïve, i.e. subject has had previous treatment with any interferon, ribavirin, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV.
3) As determined by documented records, subject is HIV positive or known to be coinfected with hepatitis B virus (HBsAg positive).
4) has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
5) has pre-existing psychiatric condition(s)
6) has any known medical condition that could interfere with the subject’s participation in and completion of the trial
7) has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
8) (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment
9) is a male whose female partner(s) are pregnant
10) has exclusionary laboratory values as listed in the protocol
i) Hemoglobin <12 g/dL for females and <13 g/dL for males.
ii) Neutrophils <1.5 x 103/µL (<1.2 x 103/µL for Blacks).
iii) Platelets <150 x 103/µL
iv) Direct bilirubin >1.5 x ULN (upper limit of normal) of the laboratory reference range
v) PT/PTT values > 10% above laboratory reference range
vi) Anti-nuclear antibodies (ANA) > 1:320
vii) ALT > 350IU/L
viii) AST > 350 IU/L
viiii) Creatinine clearance < 50 mL/min.
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