Clinical Trial testing the combination of MK-5172 and MK-8742 with Ribavirin in people with Hepatitis C

• Conditions: Hepatitis C Virus Genotype 2; MedDRA version: 14.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002169-21-ES
• Lead Sponsor: Merck Sharp & Dohme Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-18
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Be > or = to 18 years of age on day of signing informed consent.
2.Have a body weight > or = to 50 kg (111 lbs) and < or = to 125 kg (275 lbs).
3.For Part B only: have chronic HCV GT2, or GT4, or GT5 or GT6 infection
-Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA (> or = to 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 < or = to 12.5 kPa
-A FibroTest (FibroSure®) score of < or = to 0.48 and aspartate aminotransferase (AST) platelet ratio index (APRI) of < or = to1 during Screening
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, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
7.Provide written informed consent 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

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.For Part B: has HCV infection with a genotype other than GT2, GT4, GT5 or GT6, including a mixed GT infection or a non-typeable genotype.
3.Is NOT treatment naïve, i.e. subject has had previous treatment with any interferon, RBV, approved or experimental direct-acting antiviral(s), or other investigational therapies for HCV.
4.Is coinfected with hepatitis B virus (HBsAg positive) 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 Section 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
9.Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (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.(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 (see Inclusion Criterion Nº 5); 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 a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criterion Nº 5).
11.Is a male whose female partner(s) is pregnant (this is a contraindication for RBV use).
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:
-Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
-Hemoglobinopathy, including, but not limited to, thalassemia major
-Poor venous access that precludes routine peripheral blood sampling required for this trial.
-Subject with indwelling venous catheters.
-Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
-Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
13.Had a life-threatening SAE during the screening period.
14.Is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
15.Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hep

Study & Design

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