MK-3682 + MK-8408 for 12 weeks in Subjects with HCV GT1-6 Infectio
- Conditions
- Treatment of chronic hepatitis C virus (HCV) infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-003227-37-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
1. be =18 years of age on day of signing informed consent
2. have HCV RNA (=10,000 IU/mL in peripheral blood) at the time of screening
3. have documented chronic HCV GT1, GT2, GT3, GT4, GT5, or GT6 (with no evidence of non-typeable or mixed GT) infection as follows:
a. positive for anti-HCV antibody, HCV RNA, or HCV GT1, GT2, GT3, GT4, GT5, or GT6 at least 6 months before Day 1, or
b. positive for anti-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (suc as the presence of fibrosis) before Day 1
4. have liver disease staging assessment as follows:
a. Absence of cirrhosis (F0 to F3) defined as per protocol
b. Compensated cirrhosis (F4) defined as per protocol
5. have an HCV treatment status that is one of the following:
a. HCV treatment naïve (defined as no prior exposure to any IFN-containing regimen, RBV, or other approved or experimental HCV-specific DAA agent)
b. HCV treatment experienced (defined as prior virologic failure after treatment with an IFN-containing regimen, with or without RBV, or intolerance to an IFN-containing regimen). Subjects cannot have previously received treatment with HCV-specific DAA agent
6. meet one of the following categories:
a. The subject is a male
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 =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 who is of reproductive potential and agrees to avoid becoming pregnant from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations by complying with one of the following:
(1) practice abstinence† from heterosexual activity, OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are as follows‡:
Single method (one of the following is acceptable):
• intrauterine device (IUD)
• vasectomy of a female subject’s male partner
• contraceptive rod implanted into the skin
Combination method (requires use of two of the following):
• diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
• cervical cap with spermicide (nulliparous women only)
• contraceptive sponge (nulliparous women only)
• male condom or female condom (cannot be used together)
• hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection
†Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Institutional Review Boards/Ethics Review Committees/ (IRBs/ERCs). Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception
‡If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region
7. understand the study procedures, alternative treatmen
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. is cirrhotic AND is Child-Pugh Class B or C, or has a Child-Tucotte-Pugh (CTP) score >6
4. is coinfected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive)
5. is coinfected with HIV AND has a history of opportunistic infection in the preceding 6 months prior to screening
6. 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
7. has cirrhosis AND liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
8. is taking or plans to take any of the prohibited medications listed in the protocol (Section 5.5) 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 through 24 weeks after the study treatment period (FW 24)
10. is a female subject who is pregnant or breastfeeding, or expecting to conceive or donate eggs from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations, OR a male subject who is expecting to donate sperm from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations
11. 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 (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., 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 limited to: unstable angina, unstable congestive heart failure, significant arrhythmia; subjects currently under evaluation for a potentially clinically significant cardiac abnormality/dysfunction are also excluded
e. Any major medical condition, clinically-significant illness (other than HCV), pre-study laboratory or ECG abnormality, or history of any illness, which, in the opinion of the investigator, might interfere with subject treatment, assessment, compliance with the protocol, or confound the results of the study or pose additional risk in administering the study drug to the subject
f. History of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective
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