MK-5172 With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012 AM1)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01440595
First received: September 22, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

This study will evaluate the safety, tolerability, and antiviral activity of MK-5172 when administered concomitantly with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: MK-5172
Drug: Placebo to MK-5172
Drug: Peginterferon alfa-2b (Peg-IFN)
Drug: Ribavirin (RBV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 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 complete early virologic response (cEVR) in the MK-5172 treatment arms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first achievement of undetectable HCV ribonucleic acid (RNA) [ Time Frame: Baseline to Week 12 for MK-5172 treatment arms, Week 24 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of participants achieving rapid viral response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Number of participants achieving sustained viral response 12 weeks after completion of therapy (SVR12) [ Time Frame: Week 24 for MK-5172 treatment arms, Week 36 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of participants achieving sustained viral response 24 weeks after completion of therapy (SVR24) [ Time Frame: Week 36 for MK-5172 treatment arms, Week 48 for Placebo arm ] [ Designated as safety issue: No ]
  • Number of participants achieving undetectable HCV RNA at Week 12 in the Placebo arm [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of participants achieving complete early virologic response (cEVR) at Week 24 in the Placebo arm [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5172 200 mg
MK-5172 200 mg in combination with Peg-IFN and RBV for 12 weeks
Drug: MK-5172
MK-5172 once daily for 12 weeks
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Name: PegIntron®, SCH 054031
Drug: Ribavirin (RBV)
Ribavirin twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Other Name: Rebetol®, SCH 018908
Experimental: MK-5172 400 mg
MK-5172 400 mg in combination with Peg-IFN and RBV for 12 weeks
Drug: MK-5172
MK-5172 once daily for 12 weeks
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Name: PegIntron®, SCH 054031
Drug: Ribavirin (RBV)
Ribavirin twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Other Name: Rebetol®, SCH 018908
Experimental: MK-5172 800 mg
MK-5172 800 mg in combination with Peg-IFN and RBV for 12 weeks
Drug: MK-5172
MK-5172 once daily for 12 weeks
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Name: PegIntron®, SCH 054031
Drug: Ribavirin (RBV)
Ribavirin twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Other Name: Rebetol®, SCH 018908
Placebo Comparator: Placebo
Placebo to MK-5172 in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks
Drug: Placebo to MK-5172
Placebo to MK-5172 once daily for 12 weeks
Drug: Peginterferon alfa-2b (Peg-IFN)
Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
Other Name: PegIntron®, SCH 054031
Drug: Ribavirin (RBV)
Ribavirin twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Other Name: Rebetol®, SCH 018908

  Eligibility

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

Inclusion Criteria:

  • Body weight ≥ 88 lbs and ≤ 275 lbs
  • Documented CHC GT2 or GT3 infection
  • No known cirrhosis
  • Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
  • Chest X-ray within the last 6 months
  • Eye exam within the last 6 months

Exclusion Criteria:

  • Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
  • Prior approved or investigational treatment for hepatitis C
  • Evidence of hepatocellular carcinoma
  • Diabetic and/or high blood pressure with clinically significant eye exam findings
  • Pre-existing psychiatric condition
  • Clinical diagnosis of abuse of certain substances within specified timeframes
  • Known medical condition that could interfere with participation
  • Active or suspected cancer within the last 5 years
  • Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
  • Male who is planning to impregnate partner or donate sperm
  • Male with a pregnant female partner
  • Chronic hepatitis not caused by HCV
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01440595     History of Changes
Other Study ID Numbers: MK-5172-012
Study First Received: September 22, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014