MK-3682B Fixed Dose Combination (FDC) in Subjects with Chronic Hepatitis C Virus (HCV) Infectio

Phase 1

• Conditions: Chronic Hepatitis C Infected Patient; MedDRA version: 19.0Level: LLTClassification code 10019183Term: HCVSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-000620-26-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. be >or=18 years of age and >or= age of consent per local regulations on day of signing informed consent
2. HCV RNA (>or= 10,000 IU/mL in peripheral blood) at the time of screening
3. have documented chronic HCV GT5 or GT6 (with no evidence of non-typeable or mixed GT) infection and meet the definition below:
- Positive for anti-HCV antibody, HCV RNA, or HCV GT5 or GT6 at least 6 months before Day 1, or
- Positive for anti-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (such as the presence of fibrosis) before Day 1
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:
- 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 - A Fibrosure® (Fibrotest®) score of Compensated cirrhosis is defined as any one of the following:
- 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 × 100÷ (platelet count÷100) (APRI calculation to be provided by the central laboratory)
NOTE: In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy or Fibroscan is required. Liver biopsy results supersede the results obtained by Fibroscan® or Fibrosure®
6. be HCV treatment naïve (defined as no prior exposure to any interferon, RBV, or other approved or experimental HCV-specific direct-acting antiviral agent) OR prior virologic failure after treatment with an interferon-containing regimen (comprised of interferon or pegylated interferon, with or without ribavirin) only. Subjects who were intolerant to an interferon-containing regimen will be allowed to enroll. Subjects may not have previously received treatment with HCV direct-acting antiviral agents
7. meet one of the following criteria:
a. The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)
b. The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women >or=45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing
c. The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug through 14 days after taking the last dose of study drug (or longer if dictated by local regulations), by complying with one of the following: (1) practice abstinence† from heterosexu

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. 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:
a. subjects that are Child-Pugh Class B or C, or who have a Pugh-Turcotte score >6, must be excluded
NOTE To calculate the Child-Pugh score, refer to the following website: http://www.mdcalc.com/child-pugh-score-for-cirrhosis-mortality
4. is coinfected with hepatitis B virus (eg. HBsAg positive)
5. 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
6. has a history of malignancy 7. has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma or is under evaluation for HCC
NOTE If liver imaging within 6 months prior to Day 1 is not available, imaging is required during screening
8. is taking or plans to take any of the prohibited medications listed in the protocol or is taking herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum), from 2 weeks prior to Day 1 through 2 weeks after the study treatment period
9. 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 such study during the course of this study
10. Has, in the opinion of the investigator, clinically-relevant drug or alcohol abuse within 12 months of screening
11. is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 through at least 14 days after the last dose of study drug, or longer if dictated by local regulations, OR is a male subject who is expecting to donate sperm or planning to impregnate female partner(s) from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drug, or longer if dictated by local regulations
NOTE After randomization, female subjects should avoid conceiving or donating eggs and male subjects should avoid impregnating a partner or donating sperm for at least 14 days after taking the last dose of study drug
12. has any of the following conditions:
a. Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
b. Poor venous access that precludes routine peripheral blood sampling required for this trial
c. Subject with a history of gastric surgery (eg. stapling, bypass) or subject with a history of malabsorption disorders (eg. celiac sprue disease)
d. Any clinically significant cardiac abnormalities/dysfunction that may interfere with subject treatment, assessment, or compliance with the protocol, including but not

Study & Design

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