MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003 AM6)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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: | June 2014 |
| 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:
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:
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:
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:
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:
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 |
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| Contact: Toll Free Number | 1-888-577-8839 |
| United States, Kentucky | |
| Call for Information (Investigational Site 0017) | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Call for Information (Investigational Site 0014) | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Missouri | |
| Call for Information (Investigational Site 0013) | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| United States, New York | |
| Call for Information (Investigational Site 0034) | Recruiting |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Call for Information (Investigational Site 0045) | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| United States, Oklahoma | |
| Call for Information (Investigational Site 0064) | Recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Call for Information (Investigational Site 0053) | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Texas | |
| Call for Information (Investigational Site 0040) | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Call for Information (Investigational Site 0079) | Recruiting |
| Dallas, Texas, United States, 75203 | |
| United States, Virginia | |
| Call for Information (Investigational Site 0086) | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Call for Information (Investigational Site 0078) | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Argentina | |
| Merck Sharp & Dohme (Argentina) Inc. | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Alfredo Wilkinson 54 11 4796 8200 | |
| Germany | |
| Merck Sharp & Dohme GmbH | Recruiting |
| Haar, Germany | |
| Contact: Kristian Lobner 49 89 4561 1102 | |
| Puerto Rico | |
| Merck Sharp & Dohme (I.A.) Corp. | Recruiting |
| Carolina, Puerto Rico | |
| Contact: Felipe Arbelaez (787) 474-8200 | |
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01353911 History of Changes |
| Other Study ID Numbers: | 5172-003 |
| Study First Received: | May 12, 2011 |
| Last Updated: | May 15, 2013 |
| 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 Interferon Alfa-2a |
Interferon Alfa-2b Interferons Ribavirin Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013