A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection - Protocol 038: MK5172 with Peg-IFN & RBV in naive HCV GT1 patients
- Conditions
- Chronic Hepatitis C Virus InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-003333-42-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- 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 1 infection 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 a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma. A liver biopsy done prior to screening is acceptable if it is performed:
• Within 3 years of screening and the result was METAVIR (or equivalent) Stage 0 (F0) to 2 (F2).
• Within 1 year of screening and the result was Stage 3 (F3).
If the prior liver biopsy was obtained outside the acceptable windows, a repeat biopsy may be performed, and the results must show no evidence of cirrhosis and hepatocellular carcinoma in order for the subject to be randomized in the study.
For countries where liver biopsy is not performed prior to treatment and where noninvasive tests (for e.g. FibroScan and/or FibroTest) are used for staging of liver disease, these results may be used to assess eligibility. Subjects with a documented FibroScan score of =9.5 kPa, or FibroTest score of =0.58, are allowed to be enrolled in the study. These non-invasive tests done prior to screening are acceptable if they were performed within 1 year of screening and meet the indicated cut-offs.
5. 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).
6. understand the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
7. provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
The subject must be excluded from participating in the trial if the subject:
1. is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
2. has a non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype.
3. 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.
4. as determined by documented records, subject is HIV positive or known to be co-infected with hepatitis B virus (HBsAg positive).
5. has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
6. is taking or plans to take any of the following medications:
6.1. Significant inducers or inhibitors of CYP3A4 2 weeks prior to start of study medications (see Prohibited Medications, Section 5.5 for further guidance).
6.2. Herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum) 2 weeks prior to start of study medications (Day 1). Only silymarin (Milk Thistle, Silybum marianum) is permitted during the trial.
7. is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject’s medical care).
8. is diabetic and/or hypertensive with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
9. has pre-existing psychiatric condition(s)
10. has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes:
10.1.Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit OR
10.2.Multi-drug abuse (e.g., two or more of the substances listed in Exclusion Criterion 10.1): within 1 years of screening visit OR
10.3.receiving opiate agonist substitution therapy within 1 year of screening visit.
10.4.historic marijuana use is deemed excessive by a physician investigator or is interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period.
11. has any known medical condition that could interfere with the subject’s participation in and completion of the trial, (see protocol pages 27 and 28).
12.has evidence of active or suspected malignancy, or a history of malignancy, within the
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