Clinical Trial testing the combination of MK-5172 with/without MK-8742 and/or Ribavirin in people with Hepatitis C

Phase 1

• Conditions: Hepatitis C Virus Genotype 2/4/5/6; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 17.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2013-002169-21-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible for participation in this trial, the subject must:

The following applies to both Part A and Part B (unless specified otherwise)

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. For Part A only: have chronic HCV GT2 infection. The amino acid variant at position 31 in the NS5A region must be documented prior to enrollment in the trial

For Part B only: have chronic HCV GT2, or GT4, or GT5 or GT6 infection
Note: For Part B of the trial, the amino acid variant at position 31 does not need to be determined prior to enrolling GT2 subjects in treatment arm 2.

• Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA (= 10,000 IU/mL in peripheral blood) at the time of screening
• 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 absence of cirrhosis, which is defined as any one of the following:
• Liver biopsy performed within 2 years of Day 1 of this study showing absence of cirrhosis
• Fibroscan (in countries where locally approved) performed within 12 months of Day 1 of this study with a result of =12.5 kPa
• A FibroTest (FibroSure®) score of =0.48 and aspartate aminotransferase (AST) platelet ratio index (APRI) of =1 during Screening

In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroTest (FibroSure®).

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).

If acceptable by local regulatory agencies, methods of birth control allowed in the study are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, female condom, male condom with spermicide, vasectomy, and hormonal contraceptives (e.g. birth control pills, transdermal patch, or injectables) as well as true abstinence, if abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception].

For the purposes of this protocol, a woman of non-childbearing potential is defined as one who has either (1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), (2) 6 weeks post-surgical bilateral oopherectomy with or without hysterectomy, or (3) bilateral tubal ligation.

For the purposes of this protocol, a male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.

6. un

Exclusion Criteria

The subject must be excluded from 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 stuy or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures
2.For Pt A: has non GT2 HCV, including a mixed GT infection or infection with a non-typeable GT.
For Pt B: has HCV with a GT other than GT2, GT4, GT5 or GT6, including a mixed GT infection or infection with a non-typeable GT.
3. is NOT treatment naïve,
4. is coinfected with hepatitis B virus or HIV.
5. has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
6. is taking or plans to take any of the prohibited medications listed in Sec. 5.5 of this protocol within 2 weeks prior to day 1.
7. is currently participating or has participated in a study with an investigational compound 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. has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes:
a. 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 if shorter, is judged by investigator to be capable of complying with study procedures OR
b. receiving opiate agonist substitution therapy within 1 year of screening visit, or if shorter, is judged by investigator to be capable of complying with study procedures
c. history of marijuana use if deemed excessive by a physician investigator or interferes with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must agree to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period.
9. has evidence of active or suspected malignancy, or a history of malignancy, within the last 5yrs (except adequately treated carcinoma in situ, squamous cell carcinoma, and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
10. is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to 2 methods of birth control throughout treatment and after the completion of all treatment; or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using 2 methods of birth control throughout treatment and after the completion of all treatment.
11. is a male whose female partner is pregnant.
12. has any other condition which, in the opinion of the principal investigator or study physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study , including but not limited to:
a. Organ transplants other than cornea and hair
b. Hemoglobinopathy
c. Poor venous access that precludes routine peripheral blood sampling required for this trial.
d. Subject with indwelling venous

Study & Design

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