A Study of Different Durations of Treatment With MK-5172 in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01716156
First received: October 25, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This study will compare two different durations of treatment with MK-5172 in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.


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

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) [ Time Frame: Up to Week 36 ] [ Designated as safety issue: No ]
  • Number of participants experiencing at least one adverse event (AE) on study [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study therapy due to an AE [ Time Frame: Up to 24 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 48 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: Up to Week 24 ] [ Designated as safety issue: No ]
  • Number of participants achieving sustained virologic response 4 weeks after the end of all study therapy (SVR 4) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • Number of participants achieving sustained virologic response 24 weeks after the end of all study therapy (SVR 24) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5172 100 mg + RBV (12 Weeks) Drug: MK-5172
MK-5172, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment
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 100 mg + RBV (24 Weeks) Drug: MK-5172
MK-5172, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment
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:

  • Chronic, compensated HCV GT 1 hepatitis C
  • IL28B CC genotype
  • 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 cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (FibroScan and/or FibroTest)
  • Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential)

Exclusion Criteria:

  • Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype
  • Previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV
  • Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
  • Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
  • 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 study
  • Diabetes and/or hypertension with clinically significant ocular examination findings
  • Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01716156     History of Changes
Other Study ID Numbers: 5172-039
Study First Received: October 25, 2012
Last Updated: March 31, 2014
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014