MK-5172/MK-3682 with MK-8742 or MK-8408 in HCV GT1, GT2, and GT4 Infected Subjects

Phase 1

• Conditions: Chronic Hepatitis C infected patient; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003304-73-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Study Completion: 2016-12-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

The following applies to Part A and Part B (unless otherwise specified):
1. be > or = to 18 years of age
2. HCV RNA (> or = to 10,000 IU/mL in peripheral blood) at the time of screening
3. have documented chronic HCV GT1, GT2, or GT4 (NOTE: GT4 infected subjects are only eligible for enrollment in Part B) (with no evidence of non-typeable or mixed genotype) infection:
-Positive for anti-HCV antibody, HCV RNA, or any of the above HCV genotypes at least 6 months before screening, or
-Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)
4.Be otherwise healthy as determined by the medical history, physical examination, ECG, and clinical laboratory measurements performed at the time of screening
5.have liver disease staging assessment as follows:
Absence of cirrhosis is defined as any one of the following (both Part A and Part B):
-Liver biopsy performed within 24 months of Day 1 of this study showing absence of cirrhosis
-Fibroscan performed within 12 months of Day 1 of this study with a result of < or = to 12.5 kPa
-A Fibrosure® (Fibrotest®) score of< or = to 0.48 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of < or = to 1 during Screening
Compensated cirrhosis is defined as any one of the following (Part B only):
-A liver biopsy performed prior to Day 1 of this study showing cirrhosis (F4)
-Fibroscan performed within 12 calendar months of Day 1 of this study with a result >12.5 kPa
-A FibroSure® (Fibrotest®) performed during Screening with a score of >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of >2. APRI formula: AST÷lab upper limit of normal (ULN) for AST x 100÷ {platelet count÷100} (APRI calculation to be provided by the central laboratory.)
6.be HCV treatment naïve
(Read the rest in protocol)
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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 would interfere with the study procedures
2.has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease.
3.For cirrhotics (Parts B and C only):
a.subjects that are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >5, must be excluded
4.coinfected with hepatitis B virus
5.coinfected with HIV (Part A only).
6.For subjects with HIV, has a history of opportunistic infection in the preceding 6 months prior to screening. A list of these events may be found in Appendix B of the following document: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
7.has a history of malignancy 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
(Read the rest in protocol)

Study & Design

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