Safety and Efficacy of MK-5172 + MK-8742 in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052/C-SURFER)
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | March 2014 |
End Date: | August 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase II/III Randomized 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
This study will evaluate the safety and efficacy of combination treatment with MK-5172 +
MK-8742 for non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV)
infection and chronic kidney disease (CKD). After a screening period, participants will
receive random assignment to one of two study arms (immediate treatment or deferred
treatment,) or assignment to open-label immediate treatment with intensive pharmacokinetic
sampling. The primary study hypothesis is that the proportion of participants achieving a
sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.
MK-8742 for non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV)
infection and chronic kidney disease (CKD). After a screening period, participants will
receive random assignment to one of two study arms (immediate treatment or deferred
treatment,) or assignment to open-label immediate treatment with intensive pharmacokinetic
sampling. The primary study hypothesis is that the proportion of participants achieving a
sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.
Incluson criteria:
- Documented chronic (at least 6 months) HCV GT1 infection (with no evidence of mixed
genotypes or genotype that cannot be assigned a type)
- No evidence of cirrhosis (liver biopsy performed within 24 months of Day 1 of this
study showing absence of cirrhosis, or Fibroscan performed within 12 months of Day 1
of this study, or Fibrosure plus Aspartate Aminotransferase to Platelet Ratio Index
[APRI] obtained during the screening period)
- HCV treatment naive or HCV ribonucleic acid (RNA) treatment relapse after a pegylated
interferon-containing regimen
- Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29)
non-dialysis dependent or on hemodialysis for at least 3 months, including
individuals awaiting kidney transplant and those with failed kidney transplants but
no longer on immunosuppressant therapy)
- Female participant of reproductive potential must agree to remain abstinent or use
(or have their partner use) 2 acceptable methods of contraception from at least 2
weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if
dictated by local regulations
Exclusion criteria:
- Evidence of decompensated liver disease
- On peritoneal dialysis for management of kidney disease
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- History of malignancy <=5 years prior to signing informed consent
- Clinical diagnosis of substance abuse
- Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from
at least 2 weeks prior to Day 1 and until 14 days after the last study dose, or
longer if dictated by local regulations
- Organ transplant (including hematopoietic stem cell transplant) other than kidney,
cornea, and hair
- Conditions requiring, or likely to require, chronic systemic administration of
corticosteroids during the course of the trial
- Uncontrolled or poorly controlled hypertension
- Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina)
or cardiovascular procedure within 3 months prior to signing informed consent
- New or worsening signs or symptoms of congestive heart failure within 3 months of
signing informed consent
- Severe active peripheral vascular disease
- Recent (within 3 months prior to signing informed consent) episode or recurrence of
stroke, transient ischemic attack (TIA) or neurological disorder, including but not
limited to seizures
- Evidence or history of chronic hepatitis not caused by HCV
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