MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01353911
First received: May 12, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

This study will evaluate the safety, tolerability, and antiviral activity of MK-5172 when administered in combination with peginterferon (Peg-IFN alfa-2b) and ribavirin in treatment-naïve participants with chronic hepatitis C.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: MK-5172
Drug: Boceprevir
Drug: Placebo for MK-5172
Drug: Placebo for Boceprevir
Drug: Peg-interferon alfa-2b
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 Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Genotype 1 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 Viral Response (cEVR) in the MK-5172 Treatment Arms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of participants experiencing adverse events [ Time Frame: From first dose up to 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants discontinued from study due to adverse events [ Time Frame: From first dose up to Week 44 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants Achieving Sustained Viral Response 24 weeks After the End of All Study Therapy (SVR24) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: June 2011
Estimated Study Completion Date: March 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5172 100 mg
MK-5172 100 mg + Peg-IFN alfa-2b + ribavirin for 12 weeks followed by 12 or 36 weeks of Peg-IFN alfa-2b + ribavirin based on response guided therapy.
Drug: MK-5172
Orally once daily in AM
Drug: Placebo for Boceprevir
four capsules orally three times daily
Drug: Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection
Other Names:
  • PegIntron
  • Peg-IFN alfa-2b
Drug: Ribavirin
300 mg to 700 mg orally twice daily
Other Name: Rebetol
Experimental: MK-5172 200 mg
MK-5172 200 mg + Peg-IFN alfa-2b + ribavirin for 12 weeks followed by 12 or 36 weeks of Peg-IFN alfa-2b + ribavirin based on response guided therapy
Drug: MK-5172
Orally once daily in AM
Drug: Placebo for Boceprevir
four capsules orally three times daily
Drug: Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection
Other Names:
  • PegIntron
  • Peg-IFN alfa-2b
Drug: Ribavirin
300 mg to 700 mg orally twice daily
Other Name: Rebetol
Experimental: MK-5172 400 mg

MK-5172 400 mg + Peg-IFN alfa-2b + ribavirin for 12 weeks followed by 12 or 36 weeks of Peg-IFN alfa-2b + ribavirin based on response guided therapy

Participants assigned to the 400 mg MK-5172 group have been unblinded and transitioned to 100 mg MK-5172 once daily + Peg-IFN alfa-2b + ribavirin and will remain in the study

Drug: MK-5172
Orally once daily in AM
Drug: Placebo for Boceprevir
four capsules orally three times daily
Drug: Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection
Other Names:
  • PegIntron
  • Peg-IFN alfa-2b
Drug: Ribavirin
300 mg to 700 mg orally twice daily
Other Name: Rebetol
Experimental: MK-5172 800 mg

MK-5172 800 mg + Peg-IFN alfa-2b + ribavirin for 12 weeks followed by 12 or 36 weeks of Peg-IFN alfa-2b + ribavirin based on response guided therapy

Participants assigned to the 800 mg MK-5172 group have been unblinded and transitioned to 100 mg MK-5172 once daily + Peg-IFN alfa-2b + ribavirin and will remain in the study

Drug: MK-5172
Orally once daily in AM
Drug: Placebo for Boceprevir
four capsules orally three times daily
Drug: Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection
Other Names:
  • PegIntron
  • Peg-IFN alfa-2b
Drug: Ribavirin
300 mg to 700 mg orally twice daily
Other Name: Rebetol
Active Comparator: Boceprevir 800 mg
4 week lead-in Peg-IFN alfa-2b + ribavirin then Boceprevir 800 mg + Peg-IFN alfa-2b + ribavirin for 24 weeks followed by 0 or 20 weeks of Peg-IFN alfa-2b + ribavirin based on response guided therapy
Drug: Boceprevir
four 200 mg capsules orally three times daily
Other Name: Victrelis
Drug: Placebo for MK-5172
Orally once daily in AM
Drug: Peg-interferon alfa-2b
1.5 μg/kg/week subcutaneous injection
Other Names:
  • PegIntron
  • Peg-IFN alfa-2b
Drug: Ribavirin
300 mg to 700 mg orally twice daily
Other Name: Rebetol

Detailed Description:

Amendment 5 allows treatment-naïve participants with chronic hepatitis C and compensated cirrhosis to be enrolled and receive MK-5172 100 mg in combination with PegIFN alfa-2b and ribavirin, without a corresponding control arm.

  Eligibility

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

Inclusion Criteria:

  • Has previously documented chronic hepatitis C genotype 1 (CHC GT 1) infection
  • Has hepatitis C virus (HCV) ribonucleic acid (RNA value) ≥10,000 IU/mL
  • Body weight ≥40 kg (88 lbs) and ≤125 kg (275 lbs)
  • Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver disease
  • Had a liver biopsy within 3 years of screening or between screening and Day 1 with histology consistent with CHC and no evidence of cirrhosis or hepatocellular carcinoma or no other cause for chronic liver disease (for participants with compensated cirrhosis, any liver biopsy demonstrating cirrhosis regardless of length of time since biopsy)
  • Female of childbearing potential or a male with female sexual partner who is of childbearing potential agrees 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 participants with compensated cirrhosis, evidence of cirrhosis without evidence of hepatocellular carcinoma (confirmed by ultrasound within 4 weeks prior)

Exclusion Criteria:

  • Is pregnant, breastfeeding, or plans to become pregnant or donate eggs
  • Is human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis B virus
  • Has received prior approved or investigational treatment for hepatitis C
  • Has evidence of hepatocellular carcinoma or is under evaluation for hepatocellular carcinoma
  • For participants with compensated cirrhosis: alphafetoprotein level of ≥100 ng/mL
  • Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
  • Has evidence or history of chronic hepatitis not caused by HCV
  • Is 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
  • Has any known medical condition that could interfere with the patient's participation in and completion of the study
  • Pre-existing psychiatric condition including but not limited to moderate or severe depression, suicidal or homicidal ideation or attempt, schizophrenia, psychosis, bipolar disorder, post traumatic stress disorder, or mania
  • Is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
  • Member or family member of study staff
  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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01353911     History of Changes
Other Study ID Numbers: 5172-003
Study First Received: May 12, 2011
Last Updated: September 5, 2014
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
Interferon-alpha
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014