Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
- Conditions
- Hepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-003858-25-ES
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 237
-Be =18 years of age on day of signing informed consent.
-Have documented chronic (at least 6 months) HCV GT1 infection (with no evidence of non typable or mixed genotypes) :
•Positive for anti-HCV antibody, HCV RNA, or an HCV genotype
•HCV RNA (= 10,000 IU/mL in peripheral blood)
-Have no evidence of cirrhosis based on 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 =12.5 kPa[54]*
*Fibroscan cut-off of 12.5 kPa has a positive predictive value of 90% and a sensitivity of 95% for =F3. Based on box and whisker plot of interquartile distribution >12.5 kPa will exclude the majority of subjects with metavir F3 fibrosis
•A FibroSure® (Fibrotest®) score of =0.48 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of =1 during Screening
In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above critieria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroSure®.
-Have an HCV treatment status that is one of the following:
Treatment naïve: Naive to all anti-HCV treatment
Prior Treatment Relapse: Subjects relapsed after completing a prior course of HCV therapy that included IFN or PEG-IFN + Ribavirin but that did not include any direct acting antivirals.
RELAPSE: HCV RNA undetectable (‘target not detected’) at end of treatment with a Peg-IFN containing regimen, but HCV RNA quantifiable (=LLOQ) during follow-up
-Have Chronic Kidney Disease defined as:
Subjects with GFR =29 who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).
-Agree (if subject is of reproductive potential) to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to Day 1 and throughout treatment, or longer if dictated by local regulations.
If acceptable by local regulatory agencies, methods of birth control allowed in the study are: intrauterine device (IUD), diaphragm with spermicide, hormonal contraceptives (e.g., birth control pills, transdermal patch, or injectables), contraceptive sponge, female condom, male condom with spermicide or vasectomy.
Note: Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal methods, use of post-ovulation methods and withdrawal) are not acceptable methods of contraception.
-A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subjects who is not of reproductive potentials is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation.
-A male subject who is not of reproductive potential is eligible without requiring the use of con
-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.
-Evidence of decompensated liver disease manifested by the presence of or history of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. If hepatic cirrhosis is determined by liver biopsy (Stage 4 Metavir or Stage 5, 6 Ishak) participants must be excluded.
-Is on peritoneal dialysis for management of Kidney disease
-In the opinion of the investigator the subject has a high likelihood of receiv ing a renal transplant during the study treatment period (up to 24 weeks from Day 1).
-Is coinfected with hepatitis B virus (e.g. HBsAg positive) or HIV.
-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 has evidence of hepatocellular carcinoma (HCC) or is under evaluation for other active or suspected malignancy.
-Is taking or plans to take any of the prohibited medications listed in Section 5 of this protocol within 2 weeks of Day 1.
-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.
-has a clinical diagnosis of substance abuse of the following specified drugs within
specified timeframes:
-Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit or, if shorter is judged by the investigator to be capable of complying with study procedures, OR.
NOTE: Subjects receiving opiate agonist substitution therapy are not excluded from the study if, in the opinion of the investigator, the subject is capable of complying with all study procedures
-history of marijuana use is deemed excessive by a physician investigator or is
interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period.
-Female subject who is pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 and throughout treatment, or longer if dictated by local regulations or male subject who is expecting to donate sperm from at least 2 weeks prior to Day 1 and throughout treatment, or longer if dictated by local regulations.
- Has any of the following conditions:
-Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
-Poor venous access in non-dialysis patients that precludes routine peripheral blood sampling required for this trial.
-Subject with a history of ga
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