MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003 AM2)
Information source: Merck
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: MK-5172 (Drug); Boceprevir (Drug); Placebo for MK-5172 (Drug); Placebo for Boceprevir (Drug); Peg-interferon alfa-2b (Drug); Ribavirin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will evaluate the safety, tolerability, and antiviral activity of MK-5172 when
administered in combination with peginterferon and ribavirin in treatment-naïve patients
with chronic hepatitis C.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Participants Achieving complete Early Viral Response (cEVR) in the MK-5172 Treatment Arms
Secondary outcome: Number of Participants Achieving Sustained Viral Response 24 weeks After the End of All Study Therapy (SVR24)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Has previously documented chronic hepatitis C genotype 1 (CHC GT 1) infection
- Has HCV RNA value ≥10,000 IU/mL
- 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 no other cause for
chronic liver disease
- 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
Exclusion Criteria:
- Is pregnant, breastfeeding, or plans to become pregnant
- 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
- 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
- Is currently participating or has participated in a study with an investigational
compound or device within 30 days of signing informed consent
- For male participants who agree to participate in the semen substudy:
- Is taking or plans to take medications known to affect hormone levels
- Has clinical evidence of an androgen disorder, history of infertility/prior year
veneral disease/urinary tract infection or plans to undergo vasectomy
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (Argentina) Inc., Buenos Aires B1638BGN, Argentina; Recruiting
Alfredo Wilkinson, Phone: 54-11-4796-8347
Merck Sharp & Dohme B.V., Bruxelles 1180, Belgium; Recruiting
Danny DHulster, Phone: 3223734310
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Dominique Blazy, Phone: 33147548990
Msd Sharp & Dohme Gmbh, Haar D-85540, Germany; Recruiting
Thomas Lang, Phone: 49-800 67367367
Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Baruch Weinreb, Phone: 972 3 9209000
Merck Sharp & Dohme (Italia) S.P.A., Milan, Italy; Recruiting
Paola Fattore, Phone: 39 06 70192348
Call for Information, San Juan 00935, Puerto Rico; Recruiting
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Additional Information
Starting date: June 2011
Last updated: December 2, 2011
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