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Trial #NCT01717326
Hepatitis C Clinical Trials

A Study of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)


A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
Study ID: 5172-035; Secondary ID: 2012-003354-89; Source: Merck Sharp & Dohme Corp.
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 610
Start date February 2013
Completion date June 2015
Phase Phase 2
Sponsor Merck Sharp & Dohme Corp.
Summary:
This is a study of the safety and efficacy of MK-5172 in combination with MK-8742 ±
ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12
weeks after the end of all study therapy (SVR12) in each of the treatment arms.
Description:
Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible,
non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be
assigned randomly to 1 of 2 treatment arms in which they will receive MK-5172 100 mg once
daily (QD) + MK-8742 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in
which they will receive MK-5172 100 mg QD + MK-8742 50 mg QD without RBV. Treatment will
last 12 weeks.

In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA)
levels of =10,000 IU/mL will be randomly assigned to a study arm, based on absence or
presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral
therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus
(HIV); these participants will receive open-label MK-5172 (100 mg) in combination with
MK-8742 (50 mg) ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.

In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of =10,000 IU/mL will be
randomly assigned to receive open-label MK-5172 (100 mg) in combination with MK-8742 (50 mg)
± RBV. Treatment will last 8 weeks.

In Part D, TN N-C participants with HCV GT3 and HCV RNA levels of =10,000 IU/mL will be
randomly assigned to receive open-label MK-5172 (100 mg) in combination with MK-8742 (50 mg)
+ RBV for 12 or 18 weeks.
Eligibility:
Gender: Both
Age: 18 Years - N/A
Inclusion criteria:
All participants - CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part D) - Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from =2 weeks prior to Day 1 until =6 months after last dose of study drug, or longer if dictated by local regulations
Part A - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis - No evidence of advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest)
Parts B, C, and D - Treatment naïve with or without cirrhosis, or - Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or - Co-infected with human immunodeficiency virus (HIV) without cirrhosis -Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease - Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)
Exclusion criteria:
All participants - Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D) including a mixed GT infection (with a non-GT1 [Part A, Part B, and Part C] or non-GT3 [Part D]) or a non-typeable genotype - Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Currently participating or 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 study - Diabetic and/or hypertensive with clinically significant ocular examination findings - History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions - Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders - Clinical diagnosis of substance abuse - Current history of seizure disorder, stroke, or transient ischemic attack - Immunologically mediated disease - Chronic pulmonary disease - Clinically significant cardiac abnormalities/dysfunction - Active clinical gout within the last year - Hemoglobinopathy or myelodysplastic syndromes - History of organ transplants including hematopoietic stem cell transplants - Poor venous access - Indwelling venous catheter - History of gastric surgery or malabsorption disorders - Severe concurrent disease - Evidence of active or suspected malignancy, or a history of malignancy, =5 years before - Pregnant, lactating, expecting to conceive or donate eggs - Male participant with pregnant female partner - Member/family member of the investigational study or sponsor staff directly involved with this study - Evidence or history of chronic hepatitis not caused by HCV
Part A - Not treatment-naïve - Documented to be HIV positive - Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications
Parts B, C, and D - Previously received any HCV direct-acting antivirals - Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial - For participants diagnosed with diabetes mellitus, documented HbA1c >8.5%
Outcome:
Primary outcome
  • Number of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12)
    Time frame: Up to 30 weeks
  • Number of participants discontinuing study therapy due to an AE
    Time frame: Up to 18 weeks
  • Number of participants experiencing at least one Adverse Event (AE) on study
    Time frame: Up to 42 weeks
Secondary outcome
  • Number of participants achieving End-Of-Treatment Response (EOTR)
    Time frame: Up to 18 weeks
  • Number of participants achieving HCV RNA <25 IU/mL at Week 12
    Time frame: Week 12
  • Number of participants achieving HCV RNA <25 IU/mL at Week 2
    Time frame: Week 2
  • Number of participants achieving HCV RNA <25 IU/mL at Week 4
    Time frame: Week 4
  • Number of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24)
    Time frame: Up to 42 weeks
  • Number of participants achieving Sustained Virologic Response 4 weeks after the end of all therapy (SVR4)
    Time frame: Up to 22 weeks
  • Number of participants achieving undetectable HCV RNA at Week 12
    Time frame: Week 12
  • Number of participants achieving undetectable HCV RNA at Week 2
    Time frame: Week 2
  • Number of participants achieving undetectable HCV RNA at Week 4
    Time frame: Week 4
  • Time to first achievement of undetectable hepatitis C virus ribonucleic acid (HCV RNA)
    Time frame: Up to 18 weeks
Contacts:
  • Toll Free Number;
    Phone: 1-888-577-8839
Location Country Status
Call for Information (Investigational Site 0367) Arlington, Texas United States Recruiting
Sponsors:
  • Merck Sharp & Dohme Corp. - (Lead Sponsor)

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