A Study of the Combination Regimen MK-5172, MK-8742, and Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01717326
First received: October 26, 2012
Last updated: April 26, 2013
Last verified: April 2013
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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:
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:
|
| 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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717326
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, California | |
| Call for Information (Investigational Site 0363) | Recruiting |
| Anaheim, California, United States, 92801 | |
| United States, Indiana | |
| Call for Information (Investigational Site 0365) | Recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 0351) | Recruiting |
| Hillsborough, New Jersey, United States, 08844 | |
| United States, North Carolina | |
| Call for Information (Investigational Site 0356) | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Call for Information (Investigational Site 0358) | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| Call for Information (Investigational Site 0367) | Recruiting |
| Arlington, Texas, United States, 76012 | |
| Call for Information (Investigational Site 0362) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Call for Information (Investigational Site 0368) | Recruiting |
| San Antonio, Texas, United States, 78215 | |
| Denmark | |
| Merck Sharp & Dohme | Recruiting |
| Glostrup, Denmark | |
| Contact: Gert Andersen 45 43287726 | |
Sponsors and Collaborators
Merck
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: | April 26, 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 19, 2013