MK-3682 + Ruzasvir 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-PL
- 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 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 =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, and for 6 months 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 heterosexual activity, OR (2) use (or have her partner use) 2 forms of acceptable contraception during heterosexual activity.
If male, subjects must agree to use a condom with spermicide or abstain from sexual intercourse during the trial until 6 months after taking the last dose of study drug (or longer if dictated by local regulations).
Spermicides alone are not an acceptable method of contraception.
Subjects must be completely informed of the unknown risks of pregnancy and agree not to become pregnant during the time they are participating in this trial.
If there is any question that a subject will not be reliable in the use of appropriate contraceptive methods, they should not be entered into the trial.
NOTE: Subjects whose study medication regimen includes only MK-3682 + RZR (and are not treated at any time with RBV) should avoid becoming pregnant or impregnating a partner for at least 14 days after taking the last dose of study drug.
7. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for FBR. However, the subject may participate in the main trial without participating in FBR
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 has a Child-Tucotte-Pugh score >6, corresponding to a Child Class B or C.
4. is hepatitis B surface antigen (HBsAg) positive at screening
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 6 months 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 6 months after the last dose of study drug or longer if dictated by local regulations
11. is a male whose female partner(s) is/are pregnant (this is a contraindication for RBV use).
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 (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease)
d. has clinically relevant drug or alcohol abuse within 12 months of screening that may intrfere with subject treatment, assesment, or compliance with the protocol.
e. 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, unstable arrhythmia; subjects currently under evaluation for a potentially clinically significant cardiac abnormality/dysfunction are also excluded
f. 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 c
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