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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01717326
First received: October 26, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

This study is being done to compare the safety, tolerability, and efficacy of MK-5172 with 2 different doses of MK-8742 plus ribavirin (RBV) for treatment-naïve participants with genotype 1 (GT1), interferon-eligible, non-cirrhotic chronic hepatitis C (CHC).


Condition Intervention Phase
Hepatitis C
 Drug: MK-5172
Drug: MK-8742
Drug: Placebo
Drug: Ribavirin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172, MK-8742, and Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

Drug Information available for: Ribavirin
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of participants experiencing at least one adverse event (AE) on study [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study therapy due to an AE [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first achievement of undetectable hepatitis C virus ribonucleic acid (HCV RNA) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants achieving undetectable HCV RNA at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Number of participants achieving undetectable HCV RNA at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Number of participants achieving undetectable HCV RNA at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of participants achieving HCV RNA <25 IU/mL at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Number of participants achieving HCV RNA <25 IU/mL at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Number of participants achieving HCV RNA <25 IU/mL at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of participants achieving end-of-treatment response (EOTR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of participants achieving sustained virologic response (SVR) 4 weeks after the end of all therapy [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Number of participants achieving SVR 24 weeks after the end of all study therapy [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5172 + MK-8742 Lower dose + RBV Drug: MK-5172
MK-5172, tablet, orally, once daily for 12 weeks
Drug: MK-8742
MK-8742, capsule, orally, once daily for 12 weeks, at assigned dose
Drug: Placebo
Placebo to MK-8742 capsule, orally, once daily for 12 weeks to maintain blind
Drug: Ribavirin
Ribavirin capsules, orally, twice per day, at a total daily dose from 600 to 1400 mg based on participant weight
Other Names:
  • Rebetol™
  • RBV
Experimental: MK-5172 + MK-8742 Higher dose + RBV Drug: MK-5172
MK-5172, tablet, orally, once daily for 12 weeks
Drug: MK-8742
MK-8742, capsule, orally, once daily for 12 weeks, at assigned dose
Drug: Placebo
Placebo to MK-8742 capsule, orally, once daily for 12 weeks to maintain blind
Drug: Ribavirin
Ribavirin capsules, orally, twice per day, at a total daily dose from 600 to 1400 mg based on participant weight
Other Names:
  • Rebetol™
  • RBV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive for HCV genotype 1
  • 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)
  • Female participants of childbearing potential or male participant with female partners of childbearing potential, must agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 until at least 6 months after last dose of study drug, or longer if dictated by local regulations

Exclusion Criteria:

  • Mixed HCV genotype infection or non-typeable genotype
  • Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
  • Known human immunodeficiency virus (HIV) positive or known coinfection with hepatitis B virus
  • Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • Currently participating in 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 study
  • Diabetic and/or hypertensive with clinically significant ocular examination findings retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
  • 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 ideation and/or attempt, or history of severe psychiatric disorders
  • Clinical diagnosis of substance abuse
  • Current or 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
  • Poor venous access
  • Indwelling venous catheter
  • History of gastric surgery or malabsorption disorder
  • Severe concurrent disease
  • Evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years
  • Pregnant, lactating, or expecting to conceive or donate eggs
  • Male participant whose female partner is pregnant
  • Member or a family member of the investigational study staff or sponsor staff directly involved with this study
  • History of chronic hepatitis not caused by HCV
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01717326     History of Changes
Other Study ID Numbers: 5172-035, 2012-003354-89
Study First Received: October 26, 2012
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013